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                                      The Safe AQ Smart blood glucose meter is used only with Safe AQ
                                      blood glucose test strip for quantitative measurement of glucose in
                                      human whole blood as an aid for monitoring the effectiveness of
                                      diabetes control. It is intended to be used for self-testing at home by
                                      people with diabetes or near -patient testing by healthcare professionals
                                      to measure glucose in capillary whole blood. Only professionals may
                                      also test venous blood samples.
                                      The Safe AQ Voice blood glucose meter is used only with Safe AQ
         Blood Glucose                blood glucose test strip for quantitative measurement of glucose in
       Monitoring System              human whole blood as an aid for monitoring the effectiveness of
      Safe AQ Air, Safe AQ            people with diabetes or near -patient testing by healthcare professionals
             Voice)                   to measure glucose in capillary whole blood. Only professionals may
                                      also test venous blood samples.
                                      The Safe AQ Air blood glucose meter is used only with Safe AQ blood
                                      glucose test strip for quantitative measurement of glucose in human
                                      whole blood as an aid for monitoring the effectiveness of diabetes
                                      control. It is intended to be used for self-testing at home by people with
                                      diabetes or near -patient testing by healthcare professionals to measure
                                      glucose in capillary whole blood. Only professionals may also test
                                      venous blood samples.
                                      The UA101 uric acid meter is used only with UA101 uric acid test strip
       UA101 Uric Acid                for quantitative measurement of uric acid in human capillary whole
       Monitoring System              blood. It is intended to be used for self-testing at home by people as an
                                      aid in the management of hyperuricement(HUA) or gout.
                                      The Safe AQ Easy blood glucose monitoring system is intended for use
                                      in the quantitative measurement of glucose in capillary whole blood
                                      from the finger. It is intended for self-testing outside the body (in vitro
      Safe AQ Easy blood
                                      diagnostic use) by people with diabetes at home as an aid in monitoring
                                      the effectiveness of their diabetes control program. The system is
            system
                                      intended for in vitro diagnostic use only. It is intended to be used by a
                                      single person and should not be shared. It should not be used for the
                                      screening or diagnosis of diabetes or for neonatal use.
                                                                                                                    ¼¼ÊõÉóÆÀ½×¶Î      ·ñ
                                      The Safe AQ Care blood glucose monitoring system is intended for use
                                      in the quantitative measurement of glucose in capillary whole blood
                                      from the finger. It is intended for self-testing outside the body (in vitro
      Safe AO Care blood
                                      diagnostic use) by people with diabetes at home as an aid in monitoring
                                      the effectiveness of their diabetes control program. The system is
            system
                                      intended for in vitro diagnostic use only. It is intended to be used by a
                                      single person and should not be shared. It should not be used for the
                                      screening or diagnosis of diabetes or for neonatal use.
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                               Àà
                                       CardioChek brand analyzers are intended for in vitro diagnostic use to
                                       test whole blood. This system is intended for in-home (self-testing) or               2001.12.21
                                       professional use for accurately and reproducibly measuring analytes in                  »ñÅú
                                       human whole blood obtained from a fingerstick sample.
                                   The CardioChek test system (consisting of the CardioChek analyzer and
                                   PTS Panels self-test strips) is for the measurement of glucose, total
      CardioChek for Home          cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides                 2001.12.21
          Use analyzer             in capillary whole blood from the fingertip and is intended for self-                       »ñÅú
                                   testing use. This system should only be used with single-use, auto-
                                   disabling lancing devices. This system is for in vitro diagnostic use only.
                                                                                    ÈýŵÉúÎï´«¸Ð¹É·ÝÓÐÏÞ¹«Ë¾ 2026 Äê°ëÄê¶È±¨¸æÈ«ÎÄ
                                The CardioChek PA test system (consisting of the CardioChek PA
                                analyzer and PTS Panels test strips) is for the quantitative determination
       CardioChek PA            of glucose, total cholesterol, HDL (high density lipoprotein) cholesterol
                                and triglycerides in venous whole blood and capillary whole blood from                        2022.02.26
                                the fingertip and is intended for multiple patient use in professional                          »ñÅú
            (Pro)               healthcare settings. This system should only be used with single-use,
                                auto-disabling lancing devices. This system is for in vitro diagnostic use
                                only.
                                The CardioChek self-test system (consisting of the CardioChek self-test
                                analyzer and PTS Panels self-test strips) is for the measurement of
    CardioChek PA Home          glucose, total cholesterol, HDL (high density lipoprotein) cholesterol                        2022.02.26
           (OTC)                                                                                                                »ñÅú
                                intended for self-testing use. This system should only be used with
                                single-use, auto-disabling lancing devices. This system is for in vitro
                                diagnostic use only.
                                The CardioChek Plus Test System is a small portable analyzer and test
                                strip system intended for multiple patient use in professional healthcare
                                settings. This system should only be used with single-use, auto-disabling
                                lancing devices. This system is for in vitro diagnostic use only. The tests
      CardioChek Plus           strips are for the quantitative determination of glucose, total cholesterol,                  2022.02.26
          analyzer              HDL (high density lipoprotein) cholesterol and triglycerides in venous                          »ñÅú
                                whole blood and capillary whole blood from the fingertip. A Chol/HDL
                                ratio and estimated values for LDL (low density lipoprotein) cholesterol
                                and non-HDL cholesterol are calculated by the CardioChek Plus
                                analyzer.
                                       The CardioChek Plus Home test system is a small, portable analyzer and
                                       test strip system for self-testing by lay users. It is intended to be used by
                                       a single person and should not be shared. This system is for in vitro
                                       diagnostic use only. This system should only be used with single-use,
    CardioChek Plus Self-              auto-disabling lancing devices. The test strips are for the quantitative               2022.02.26
       Test Analyzer                   determination of glucose, total cholesterol, HDL (high density                           »ñÅú
                                       lipoprotein) cholesterol, and triglycerides in capillary whole blood from
                                       the fingertip. A Chol/HDL ratio and estimated values for LDL (low
                                       density lipoprotein) cholesterol and non-HDL cholesterol are calculated
                                       by the CardioChek Plus Home analyzer.
                                       The CardioChek PA and CardioChek Plus test systems (consisting of
                                       the CardioChek PA and CardioChek Plus professional analyzers and
                                       PTS Panels CHOL+GLU test strips) is for the quantitative
       PTS PANELS                                                                                                            2022.02.26
                                       determination of total cholesterol and glucose in venous whole blood
                                       and capillary whole blood from the fingertip and is intended for multiple                »ñÅú
         Test Strips
                                       patient use in professional healthcare settings. This system should only
                                       be used with single-use, auto-disabling lancing devices. This system is
                                       for in vitro diagnostic use only.
                                       The CardioChek PA and CardioChek Plus test systems (consisting of
                                       the CardioChek PA and CardioChek Plus professional analyzers and
                                       PTS Panels CHOL+HDL test strips) is for the quantitative
       PTS PANELS                      determination of total cholesterol and HDL (high density lipoprotein)                  2022.02.26
                                                                                                                                »ñÅú
        Test Strips                    fingertip and is intended for multiple patient use in professional
                                       healthcare settings. This system should only be used with single-use,
                                       auto-disabling lancing devices. This system is for in vitro diagnostic use
                                       only.
                                       The CardioChek PA and CardioChek Plus test systems (consisting of
                                       the CardioChek PA and CardioChek Plus professional analyzers and
                                       PTS Panels CHOL+HDL+GLU test strips) is for the quantitative
      PTS PANELS                      determination of total cholesterol, HDL (high density lipoprotein)                     2022.02.26
                                                                                                                                »ñÅú
        Test Strips                    blood from the fingertip and is intended for multiple patient use in
                                       professional healthcare settings. This system should only be used with
                                       single-use, auto-disabling lancing devices. This system is for in vitro
                                       diagnostic use only.
                                                                                   ÈýŵÉúÎï´«¸Ð¹É·ÝÓÐÏÞ¹«Ë¾ 2026 Äê°ëÄê¶È±¨¸æÈ«ÎÄ
                                       PTS Panels cholesterol test strips are for the quantitative
                                       determination of total cholesterol in venous whole blood and capillary
        PTS PANELS                    whole blood from the fingertip. Cholesterol measurements are used in                 1998.07.22
     Cholesterol Test Strips           the diagnosis and treatment of disorders involving excess cholesterol in               »ñÅú
                                       the blood and lipid and lipoprotein metabolism disorders. This system is
                                       intended for professional use.
                                       PTS Panels cholesterol self-test strips are for the quantitative
                                       measurement of total cholesterol in capillary whole blood from the
                                       fingertip. Cholesterol measurements are used in the diagnosis and
        PTS PANELS                    treatment of disorders involving excess cholesterol in the blood and lipid           1999.06.24
                                                                                                                              »ñÅú
                                       testing use.
                                       When using this test, do not take any decision of medical relevance
                                       without first consulting your medical practitioner.
                                  The CardioChek Plus glucose test system is intended for the quantitative
                                  determination of glucose in human whole blood for use by healthcare
   PTS Panels eGLU Test          professionals. Glucose measurements are used in the diagnosis and                         2022.02.26
           Strips                 treatment of carbohydrate metabolism disorders including diabetes                           »ñÅú
                                  mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of
                                  pancreatic islet cell carcinoma.
                                This system is intended for the quantitative determination of glucose in
                                human whole blood for use by healthcare professionals. Glucose
   PTS PANELS Glucose          measurements are used in the diagnosis and treatment of carbohydrate                        2022.02.26
        Test Strips             metabolism disorders including diabetes mellitus, neonatal                                    »ñÅú
                                hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell
                                carcinoma.
                                       The Lipid Panel Test Strips are intended to measure cholesterol, HDL
                                       cholesterol and triglycerides in whole blood on a CardioChek brand
                                       analyzer. The test strips are intended to be used by healthcare
                                       professionals to measure three blood analytes: cholesterol, HDL
                                       cholesterol and triglycerides. Cholesterol measurements are used in the
      PTS PANELS Lipid                 diagnosis and treatment of disorders involving excess cholesterol in the             2022.02.26
                                                                                                                              »ñÅú
                                       measurements are used in the diagnosis and treatment of lipid disorders
                                       (such as diabetes mellitus), atherosclerosis, and various liver and renal
                                       diseases. Triglycerides measurements are used in the diagnosis and
                                       treatment of patients with diabetes mellitus, nephrosis, liver obstruction,
                                       other diseases involving lipid metabolism, or various endocrine
                                       disorders
                                     PTS Panels Triglycerides test strips are intended to measure
                                     triglyceride in whole blood for use in the diagnosis and treatment of                  2000.05.24
        PTS PANELS
   Triglycerides Test Strips                                                                                                  »ñÅú
                                     involving lipid metabolism, or various endocrine disorders. This testing
                                     system is intended for professional use.
      MultiChem Controls               For use with PTS Panels test strips as quality control materials to
      (glu, chol, HDL, trig)                                                                                                  »ñÅú
                                       test system.
                                       For use with PTS Panels professional test strips as quality control                 2002.08.21
                                                                                                                              »ñÅú
                                       deviations of your test system.
                               The A1CNow+ test provides quantitative measurement of glycated
     A1CNOW+ TEST KIT          haemoglobin levels in capillary (fingerprick) or venous whole blood.                         2009.05.14
                                                                                                                              »ñÅú
           USE)                diabetes and as an aid to diagnose diabetes and identify patients at risk
                               of developing diabetes.
                                        The A1CNow+ test provides quantitative measurement of glycated
                                        haemoglobin levels in capillary (fingerprick) or venous whole blood.                2009.05.14
        A1CNOW SELF
           CHECK                                                                                                              »ñÅú
                                        diabetes and as an aid to diagnose diabetes and identify patients at risk
                                        of developing diabetes.
                                                                                 ÈýŵÉúÎï´«¸Ð¹É·ÝÓÐÏÞ¹«Ë¾ 2026 Äê°ëÄê¶È±¨¸æÈ«ÎÄ
                                     The A1CNow Self Check test system provides a quantitative
     A1CNow Self Check test          measurement of the percent of glycated hemoglobin levels in capillary                       2009.05.14
           system                    (fingerstick) blood samples. The test is for home use to monitor                              »ñÅú
                                     glycemic control in people with diabetes.
                                     The A1CNow+ Controls are intended for the quality control of PTS
                                     Diagnostics¡¯ A1Cnow HbA1c tests
                                     The CardioChek Plus Test System is a small portable analyzer and test
                                     strip system intended for multiple patient use in professional healthcare
                                     settings. This system should only be used with single-use, auto-disabling
      CardioChek Plus                lancing devices. This system is for in vitro diagnostic use only. The tests
          analyzer                   strips are for the quantitative determination of glucose, total cholesterol,                2023.01.17
                                                                                                                                   »ñÅú
           IVDR                      whole blood and capillary whole blood from the fingertip. A Chol/HDL
                                     ratio and estimated values for LDL (low density lipoprotein) cholesterol
                                     and non-HDL cholesterol are calculated by the CardioChek Plus
                                     analyzer.
                                     The CardioChek PA and CardioChek Plus test systems (consisting of
                                     the CardioChek PA and CardioChek Plus professional analyzers and
    PTS PANELS                      PTS Panels CHOL+HDL+GLU test strips) is for the quantitative
                                     determination of total cholesterol, HDL (high density lipoprotein)
   CHOL+HDL+GLU                                                                                                                  2023.10.04
                                                                                                                                   »ñÅú
      Test Strips                    blood from the fingertip and is intended for multiple patient use in
        IVDD                         professional healthcare settings. This system should only be used with
                                     single-use, auto-disabling lancing devices. This system is for in vitro
                                     diagnostic use only.
                                     PTS Panels cholesterol test strips are for the quantitative determination
       PTS PANELS                   of total cholesterol in venous whole blood and capillary whole blood
       Cholesterol Test              from the fingertip. Cholesterol measurements are used in the diagnosis                      2023.10.04
                                                                                                                                   »ñÅú
           Strips
           IVDD                      lipid and lipoprotein metabolism disorders. This system is intended for
                                     professional use.
       PTS PANELS                   PTS Panels cholesterol test strips are intended to measure total
                                     cholesterol in whole blood on a CardioChek Plus analyzer and provide a
       Cholesterol Test                                                                                                          2023.04.11
                                                                                                                                   »ñÅú
           Strips                    used to screen and monitor excess cholesterol in the blood and to aid in
           IVDR                      the diagnosis of lipid and lipoprotein metabolism disorders.
                                     The CardioChek Plus glucose test system is intended for the quantitative
     PTS Panels eGLU                determination of glucose in human whole blood for use by healthcare
                                     professionals. Glucose measurements are used in the diagnosis and                           2023.10.04
                                                                                                                                   »ñÅú
          IVDD                       mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of
                                     pancreatic islet cell carcinoma.
                                     The Lipid Panel Test Strips are intended to measure cholesterol, HDL
                                     cholesterol and triglycerides in whole blood on a CardioChek brand
                                     analyzer. The test strips are intended to be used by healthcare
                                     professionals to measure three blood analytes: cholesterol, HDL
                                     cholesterol and triglycerides. Cholesterol measurements are used in the
     PTS PANELS Lipid                diagnosis and treatment of disorders involving excess cholesterol in the                    2023.10.04
                                                                                                                                   »ñÅú
           IVDD                      measurements are used in the diagnosis and treatment of lipid disorders
                                     (such as diabetes mellitus), atherosclerosis, and various liver and renal
                                     diseases. Triglycerides measurements are used in the diagnosis and
                                     treatment of patients with diabetes mellitus, nephrosis, liver obstruction,
                                     other diseases involving lipid metabolism, or various endocrine
                                     disorders
                                     PTS Panels lipid panel test strips are intended to measure total
     PTS PANELS Lipid                cholesterol, HDL cholesterol, and triglycerides in whole blood on a                         2023.04.11
                                                                                                                                   »ñÅú
           IVDR                      from the lipid panel test strip may be used to screen for, monitor, or aid
                                     in the diagnosis of lipid disorders.
         Multi-Chem
                                     For use with PTS Panels test strips as quality control materials to
           Controls                                                                                                              2023.10.04
                                                                                                                                   »ñÅú
       (glu, chol, HDL,              test system.
              trig)
                                                                          ÈýŵÉúÎï´«¸Ð¹É·ÝÓÐÏÞ¹«Ë¾ 2026 Äê°ëÄê¶È±¨¸æÈ«ÎÄ
                             The A1CNow+ test provides quantitative measurement of glycated
                             haemoglobin levels in capillary (fingerprick) or venous whole blood.                         2023.10.04
                                                                                                                            »ñÅú
                             diabetes and as an aid to diagnose diabetes and identify patients at risk
                             of developing diabetes.
                             The A1CNow+ test provides quantitative measurement of glycated
                             haemoglobin levels in capillary (fingerprick) or venous whole blood.                         2023.10.04
                                                                                                                            »ñÅú
                             diabetes and as an aid to diagnose diabetes and identify patients at risk
                             of developing diabetes.
                             The A1CNow Self Check test system provides a quantitative
                             measurement of the percent of glycated hemoglobin levels in capillary
                             (fingerstick) blood samples. The test is for home use to monitor
   A1C Now+ 4 count Self glycemic control in people with diabetes.                                                        2023.10.04
                                                                                                                            »ñÅú
         OTC          Test If you need further help, call 1-877-870-5610.
                             We invite you to call and we will guide you through the test.
                             Do not take any decision of medical relevance without first consulting
                             your medical practitioner.
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       CardioChek PA Analyzer      20162221859
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       Triglycerides Test Strips
      ¸ßÃܶÈÖ¬µ°°×µ¨¹Ì´¼¼ì²âÌõ
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                                The TRUE METRIX Self Monitoring Blood Glucose System is intended for the
                                quantitative measurement of glucose (sugar) in fresh capillary whole blood samples
                                drawn from the fingertip or forearm. The TRUE METRIX Self Monitoring Blood
                                Glucose System is intended to be used by a single person and not shared. The
                                TRUE METRIX Self Monitoring Blood Glucose System is intended for self-testing
                                outside the body (in vitro diagnostic use) by people with diabetes at home as an aid
                                to monitor the effectiveness of diabetes control. The TRUE METRIX Self
                                Monitoring Blood Glucose System should not be used for the diagnosis or
                                screening of diabetes or for neonatal use. Alternative site testing should be done
                                only during steady-state times (when glucose is not changing rapidly). The TRUE
     TRUE METRIX                METRIX Test Strips are for use with the TRUE METRIX Self Monitoring Meter to
     Self Monitoring            quantitatively measure glucose (sugar) in fresh capillary whole blood samples
      Blood Glucose             drawn from the fingertip or forearm. Type of Use: Prescription £¦ Over the
      System/TRUE               Counter.
       Professional             intended for the quantitative measurement of glucose (sugar) in fresh capillary
       Monitoring               whole blood samples drawn from the fingertip or forearm and venous whole blood.
      Blood Glucose             The TRUE METRIX PRO Professional Monitoring Blood Glucose System is
          System                intended for multiple-patient use in professional healthcare settings. Testing is
                                performed outside the body (in vitro diagnostic use) as an aid to monitor the
                                effectiveness of diabetes control. The TRUE METRIX PRO Professional
                                Monitoring Blood Glucose System is used only with single-use, auto-disabling
                                lancing devices. The system is not to be used for neonates or for the diagnosis or
                                screening of diabetes. Alternative site testing should be done only during steady-
                                state times (when glucose is not changing rapidly). The TRUE METRIX PRO Test
                                Strips are for use with the TRUE METRIX PRO Blood Glucose Meter to
                                quantitatively measure glucose (sugar) in fresh capillary whole blood samples
                                drawn from the fingertip or forearm or venous whole blood. Type of Use:
                                Prescription £¦ Over the Counter.
                                The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for
                                the quantitative measurement of glucose (sugar) in fresh capillary whole blood
                                samples drawn from the fingertip. The TRUE METRIX GO Self Monitoring Blood
     TRUE METRIX                Glucose System is intended to be used by a single person and not shared. The
         GO Self                TRUE METRIX GO Self Monitoring Blood Glucose System is intended for self-
      Blood Glucose             an aid to monitor the effectiveness of diabetes control. The TRUE METRIX GO
         System                 Self Monitoring Blood Glucose System should not be used for the diagnosis or
                                screening of diabetes or for neonate use. Type of Use: Prescription £¦ Over the
                                Counter.
                                                                            ÈýŵÉúÎï´«¸Ð¹É·ÝÓÐÏÞ¹«Ë¾ 2026 Äê°ëÄê¶È±¨¸æÈ«ÎÄ
                              The TRUE METRIX AIR Self Monitoring Blood Glucose System is intended for
                              the quantitative measurement of glucose (sugar) in fresh capillary whole blood
                              samples drawn from the fingertip or forearm. TRUE METRIX AIR Self Monitoring
                              Blood Glucose System is intended to be used by a single person and not shared.
                              The TRUE METRIX AIR Self Monitoring Blood Glucose System is intended for
                              self-testing outside the body (in vitro diagnostic use) by people with diabetes at
                              home as an aid to monitor the effectiveness of diabetes control. The TRUE
                              METRIX AIR Self Monitoring Blood Glucose System should not be used for the
    TRUE METRIX               diagnosis or screening of diabetes or for neonate use. Alternative site testing can
        AIR Self              only be performed during steady-state blood times (when glucose is not changing
      Monitoring              rapidly). The TRUE METRIX Self Monitoring Test Strips are for use with the
     Blood Glucose            TRUE METRIX AIR Self Monitoring Meter to quantitatively measure glucose
        System/               (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.
       AIR PRO                intended for the quantitative measurement of glucose (sugar) in fresh capillary
      Professional            whole blood samples drawn from the fingertip or forearm and venous whole blood.
      Monitoring              The TRUE METRIX AIR PRO Professional Blood Glucose System is intended for
     Blood Glucose            multiple patient use in professional healthcare settings. Testing is performed outside
        System                the body (in vitro diagnostic use) as an aid to monitor the effectiveness of diabetes
                              control. The TRUE METRIX AIR PRO Professional Monitoring Blood Glucose
                              System is used only with single-use, auto-disabling lancing devices. The system is
                              not to be used for neonates or for the diagnosis or screening of diabetes. Alternative
                              site testing should be done only during steady-state times (when glucose is not
                              changing rapidly). The TRUE METRIX PRO Test Strips are for use with the TRUE
                              METRIX AIR PRO Professional Blood Glucose Meter to quantitatively measure
                              glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or
                              forearm or venous whole blood. Type of Use: Prescription £¦ Over the Counter.
                              The TRUEdraw Lancing Device is for use with a disposable sterile lancet for the
                              hygienic collection of capillary blood for testing purposes from the side of a
                              fingertip and from alternative sites, such as the forearm. The Mini Lancing Device
      TRUEdraw
                              is for use with a disposable sterile lancet for the hygienic collection of capillary
    Lancing Device
     Mini Lancing
                              such as the forearm. The TRUEdraw Lancing Device/ Mini Lancing Device is for
       Device
                              use only on a single patient in a home setting. The TRUEdraw Lancing Device/
                              Mini Lancing Device is not suitable for use by healthcare professionals with
                              multiple patients in a healthcare setting. Type of Use: Over the Counter.
                              The TRUEmanager Data Management Software is intended for use in home or in
    TRUEmanager               clinical settings, for single or multi-patient use, to assist people with diabetes as
      Diabetes
     Management               historical blood glucose test results to support effective diabetes management. Type
      Software
                              of Use: Over the Counter.
                              The TRUE METRIX Blood Glucose Monitoring System is a medical device
                              intended to be used in vitro for the measurement of glucose in human whole blood
                              for the purpose of monitoring the effectiveness of diabetes control. The TRUE
                              METRIX Blood Glucose Meter is intended for the quantitative determination of
                              from the vein (venous). The System may not be used for neonates. The System is
                              intended for at-home use (self-testing) and for use by Healthcare Professionals in
                              both physicians¡¯ offices and in acute and convalescent-care bedside testing facilities
                              in order to assist in the management of diabetes.
                              The TRUE METRIX GO Blood Glucose Monitoring System is a medical device
                              intended to be used in vitro for the measurement of glucose in human whole blood
                              for the purpose of monitoring the effectiveness of diabetes control. The TRUE
                              METRIX GO Blood Glucose Monitoring System is intended for the quantitative
                              determination of glucose (sugar) in fresh, human whole blood taken from the
    TRUE METRIX
        GO
                              for at-home use (self-testing by a single person and not shared) and for use by
                              healthcare professionals for multiple-patient use in professional healthcare settings.
                              The system is not to be used on neonates or for the diagnosis or screening of
                              diabetes mellitus. Alternate site (forearm) testing can only be performed during
                              steady-state blood glucose conditions.
                                                                                 ÈýŵÉúÎï´«¸Ð¹É·ÝÓÐÏÞ¹«Ë¾ 2026 Äê°ëÄê¶È±¨¸æÈ«ÎÄ
                                  The TRUE METRIX AIR Blood Glucose Monitoring System is a medical device
                                  intended to be used in vitro for the measurement of glucose in human whole blood
                                  for the purpose of monitoring the effectiveness of diabetes control with wireless
                                  transmission capability via Bluetooth Smart of results stored in meter memory. The
                                  TRUE METRIX AIR Blood Glucose Monitoring System is intended for the
     TRUE METRIX
         AIR
                                  from the fingertip or forearm (capillary) or from the vein (venous). The system is
                                  intended for at-home use (self-testing by a single person and not shared) and for use
                                  by Healthcare Professionals for multiple patient use in professional healthcare
                                  settings. The system is not to be used on neonates or for the diagnosis or screening
                                  of diabetes mellitus.
                                  TRUEdraw Lancing Devices are single patient reusable medical devices intended to
       TRUEdraw                   be used in conjunction with a lancet in the penetration of human skin to obtain a
     Lancing Device               capillary whole blood samples for blood glucose monitoring. The devices can be
                                  used for normal fingertip lancing or for alternate site testing.
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                                  The TRUEplus Lancets are intended for single use only in the penetration of human
       TRUEplus                   skin of the finger (or other alternate sites such as forearm) to obtain a capillary
        Lancets                   whole blood sample. They are intended for use by lay users. The intended
                                  population for the TRUEplus lancets is people over 6 months.
                            The TRUE METRIX Blood Glucose Monitoring System is a medical device
                            intended to be used in vitro for the measurement of glucose in human whole blood
                            for the purpose of monitoring the effectiveness of diabetes control.
                   Class C The TRUE METRIX Blood Glucose Meter is intended for the quantitative
                 (2017/746) determination of glucose in human whole blood taken from the fingertip or forearm
                            (capillary) or from the vein (venous). The System may not be used for neonates.
                            The System is intended for at-home use (self-testing) and for use by Healthcare
                            Professionals in both physicians¡¯ offices and in acute and convalescent-care bedside
                            testing facilities in order to assist in the management of diabetes.
                                                              ÈýŵÉúÎï´«¸Ð¹É·ÝÓÐÏÞ¹«Ë¾ 2026 Äê°ëÄê¶È±¨¸æÈ«ÎÄ
              The TRUE METRIX GO Blood Glucose Monitoring System is a medical device
              intended to be used in vitro for the measurement of glucose in human whole blood
              for the purpose of monitoring the effectiveness of diabetes control.
              The TRUE METRIX GO Blood Glucose Monitoring System is intended for the
TRUE METRIX   quantitative determination of glucose (sugar) in fresh, human whole blood taken
    GO        from the fingertip or forearm (capillary) and from the vein (venous). The System is
              intended for at-home use (self-testing by a single person and not shared) and for use
              by healthcare professionals for multiple-patient use in professional healthcare
              settings. The system is not to be used on neonates or for the diagnosis or screening
              of diabetes mellitus. Alternate site (forearm) testing can only be performed during
              steady-state blood glucose conditions.
              The TRUE METRIX AIR Blood Glucose Monitoring System is a medical device
              intended to be used in vitro for the measurement of glucose in human whole blood
              for the purpose of monitoring the effectiveness of diabetes control with wireless
              transmission capability via Bluetooth Smart of results stored in meter memory. The
              TRUE METRIX AIR Blood Glucose Monitoring System is intended for the
TRUE METRIX
              quantitative measurement of glucose (sugar) in fresh, human whole blood taken
    AIR
              from the fingertip or forearm (capillary) or from the vein (venous). The system is
              intended for at-home use (self-testing by a single person and not shared) and for use
              by Healthcare Professionals for multiple patient use in professional healthcare
              settings. The system is not to be used on neonates or for the diagnosis or screening
              of diabetes mellitus.
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Polymer Technology Systems,Inc.                                 ÃÀ¹úÓ¡µÚ°²ÄÉÖÝ    ÃÀ¹úÓ¡µÚ°²ÄÉÖÝ    Ò½ÁÆÆ÷е                100.00% ºÏ²¢Ôö¼Ó
PTS Diagnostics California,Inc.                                 ÃÀ¹úÓ¡µÚ°²ÄÉÖÝ    ÃÀ¹úÓ¡µÚ°²ÄÉÖÝ    Ò½ÁÆÆ÷е                100.00% ³ö×ʳÉÁ¢
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PTS Diagnostics India Private Limited       100,000.00 Ó¡¶È¬±È     Ó¡¶È°à¼ÓÂÞ¶û     Ó¡¶È°à¼ÓÂÞ¶û     Ò½ÁÆÆ÷е      100.00%        ³ö×ʳÉÁ¢
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Sinocare Healthcare Philippines,Inc.      11,000,000.00 ·ÆÂɱö±ÈË÷   ·ÆÂɱöÂí¿¨µÙÊÐ    ·ÆÂɱöÂí¿¨µÙÊÐ    Ͷ×ʼ°Ã³Ò×     99.00%     1.00% ³ö×ʳÉÁ¢
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Trividia Health Inc.                             1.00 ÃÀÔª        ÃÀ¹ú·ðÂÞÀï´ïÖÝ    ÃÀ¹úÌØÀ­»ªÖÝ     ÖÆÔìÉú²ú                55.00% ºÏ²¢Ôö¼Ó
Trividia Manufacturing Solutions, Inc.                          ÃÀ¹úк±²¼Ê²¶ûÖÝ   ÃÀ¹úк±²¼Ê²¶ûÖÝ   ÖÆÔìÉú²ú                55.00% ºÏ²¢Ôö¼Ó
Trividia Meditech, LLC.                                         ÃÀ¹ú·ðÂÞÀï´ïÖÝ    ÃÀ¹ú·ðÂÞÀï´ïÖÝ    ÖÆÔìÉú²ú                55.00% ºÏ²¢Ôö¼Ó
Trividia Healthcare Systems, LLC.                               ÃÀ¹ú·ðÂÞÀï´ïÖÝ    ÃÀ¹ú·ðÂÞÀï´ïÖÝ    Ñз¢                  55.00% ºÏ²¢Ôö¼Ó
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Trividia Health,Canada, Ltd.                                    ¼ÓÄô󰲴óÂÔ     ¼ÓÄô󰲴óÂÔ     Êг¡ÓªÏú                55.00% ºÏ²¢Ôö¼Ó
Trividia Health Mexico,S De R.L. De CV                          Ä«Î÷¸çÒÁ´ï¶û¸êÖÝ   Ä«Î÷¸çÒÁ´ï¶û¸êÖÝ   Êг¡ÓªÏú                55.00% ºÏ²¢Ôö¼Ó
Trividia Health UK Ltd                                          Ó¢¹úÂ×¶Ø       Ó¢¹úÂ×¶Ø       Êг¡ÓªÏú                55.00% ºÏ²¢Ôö¼Ó
NTH Brands, LLC.                                                ÃÀ¹ú·ðÂÞÀï´ïÖÝ    ÃÀ¹ú·ðÂÞÀï´ïÖÝ    µç×ÓÉÌÎñ                55.00% ºÏ²¢Ôö¼Ó
TD Health, LLC.                                                 ÃÀ¹ú·ðÂÞÀï´ïÖÝ    ÃÀ¹ú·ðÂÞÀï´ïÖÝ    µç×ÓÉÌÎñ                55.00% ºÏ²¢Ôö¼Ó
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