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The AffirmNow Creatinine Test Strips are used only with AffirmNow
AffirmNow Creatinine Analyzers. It is for quantitative measurement of creatinine
Creatinine Test Class B in capillary (fingerstick) whole blood or venous whole blood.
Strips Creatinine measurements may be used to monitor renal dialysis and
an aid in the diagnosis and monitor renal diseases. 2025.06.24 »ñµÃ
CE ÈÏÖ¤
The AffirmNow Creatinine Control Solution is for use only with
AffirmNow
AffirmNow Creatinine Analyzer and AffirmNow Creatinine Test
Creatinine Control Class B
Strips to check that the analyzer and test strip are working together
Solution
properly and that the test is performing correctly.
iCan view Glucose Data Reader is used to display iCan CGM glucose
data sent from the transmitter. It also provides alerts based on the
iCan view Glucose glucose settings you choose. Reader is used with iCan CGM only.
iCGM-V3) indicated for the management of diabetes for people age 2 years and CE ÈÏÖ¤
older. It is intended to replace fingerstick blood glucose testing for
diabetes treatment decisions.
The AffirmNow Creatinine Analyzer is a small, portable analyzer for
AffirmNow healthcare professionals to perform near patient testing. The analyzer 2025.06.15 »ñµÃ
Creatinine Analyzer is intended for multiple patient use and is intended for in vitro CE ×ÔÎÒÐû³Æ
diagnostic use only. This product is not to be used on neonates.
The Portable Automatic Multi-Function Analyzer is intended to be
used with compatible reagent kits in laboratories of medical
Portable Automatic institutions and clinical departments. It is suitable for the
automatically and quantitatively detection of the biochemical,
Multi-Function 2025.06.15 »ñµÃ
Analyzer£¨iCARE-
from the fingertip (capillary) or from the vein (venous), serum, CE ×ÔÎÒÐû³Æ
intended to be used by professional users for near patient testing or
laboratory testing as an aid of diagnosis related disease.
Continuous Glucose Monitoring System (CGM System) is a real
time, continuous glucose monitoring device indicated for the
measuring glucose in the interstitial fluid in persons age 2 years and
older. It is intended to replace fingerstick blood glucose testing for
diabetes treatment decisions.
Continuous Glucose
The CGM System also detects trends and tracks patterns, and aids in
Monitoring System 2025.07.02 »ñµÃ
(model: i6, H6, i7 CE ÈÏÖ¤
facilitating both acute and long-term therapy adjustments.
and H7)
Interpretation of the CGM System results should be based on the
glucose trends and several sequential readings over time.
The CGM System can be used in conjunction with smart devices with
corresponding application where the user manually controls actions
for therapy decisions.
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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 KUG-11 multi-monitoring system is intended for use in the
quantitative measurement of glucose in fresh
capillary/venous/arterial/neonatal whole blood, the uric acid and the
blood ketone in fresh capillary/venous whole blood. It is intended to be
used for near-patient testing by healthcare professionals or self-testing
Multi-monitoring at home by people as
System
(model: KUG-11, KUG-
venous blood samples.
The KUG-12 multi-monitoring system is intended for use in the
quantitative measurement of glucose, uric acid and blood ketone in
fresh capillary whole blood. It is intended to be used for self-testing at
home by people as an aid for monitoring the effectiveness of diabetes
and hyperuricement(HUA) control.
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.
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The Sinocare blood ketone control solution is for use only with Multi-
Sinocare Blood Ketone monitoring Meter and Blood Ketone test strip produced by Sinocare to
Control Solution check that they are working together properly and that the test is
performing correctly. It is for self-testing or near-patient testing.
The Sinocare uric acid control solution is for use only with Uric Acid
Meter or Multi-monitoring Meter and Uric Acid test strip produced by
Sinocare Uric Acid
Control Solution
and the test is performing correctly. It is for self-testing or near-patient
testing.
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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 in 2001.12.21
Use analyzer capillary whole blood from the fingertip and is intended for self-testing use. »ñÅú
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 test system (consisting of the CardioChek PA analyzer
and PTS Panels test strips) is for the quantitative determination of glucose,
CardioChek PA total cholesterol, HDL (high density lipoprotein) cholesterol and 2022.02.26
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 glucose,
CardioChek PA Home total cholesterol, HDL (high density lipoprotein) cholesterol and 2022.02.26
(OTC) triglycerides in capillary whole blood from the fingertip and is intended for »ñÅú
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 strips are 2022.02.26
CardioChek Plus
analyzer
density lipoprotein) cholesterol and triglycerides in venous whole blood and
»ñÅú
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, auto-disabling
CardioChek Plus Self- 2022.02.26
Test Analyzer »ñÅú
glucose, total cholesterol, HDL (high density 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 determination of
PTS PANELS
total cholesterol and glucose in venous whole blood and capillary whole 2022.02.26
blood from the fingertip and is intended for multiple patient use in »ñÅú
Test Strips 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.
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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 determination of
PTS PANELS
total cholesterol and HDL (high density lipoprotein) cholesterol in venous 2022.02.26
whole blood and capillary whole blood from the fingertip and is intended for »ñÅú
Test Strips 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 determination
PTS PANELS 2022.02.26
of total cholesterol, HDL (high density lipoprotein) cholesterol and glucose
in venous whole blood and capillary whole blood from the fingertip and is »ñÅú
Test Strips 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.
PTS Panels cholesterol test strips are for the quantitative determination of
total cholesterol in venous whole blood and capillary whole blood from the
PTS PANELS fingertip. Cholesterol measurements are used in the diagnosis and treatment 1998.07.22
Cholesterol Test Strips of disorders involving excess cholesterol in the blood and lipid and »ñÅú
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
PTS PANELS measurements are used in the diagnosis and treatment of disorders involving
disorders. This system is intended for self-testing use. »ñÅú
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 treatment 2022.02.26
Strips of carbohydrate metabolism disorders including diabetes mellitus, neonatal »ñÅú
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 2022.02.26
Test Strips
metabolism disorders including diabetes mellitus, neonatal hypoglycemia,
»ñÅú
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
PTS PANELS Lipid triglycerides. Cholesterol measurements are used in the diagnosis and
treatment of disorders involving excess cholesterol in the blood and lipid and 2022.02.26
lipoprotein metabolism disorders. Lipoprotein measurements are used in the »ñÅú
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 diabetes mellitus, 2000.05.24
PTS PANELS
Triglycerides Test Strips various endocrine disorders. This testing system is intended for professional
»ñÅú
use.
MultiChem Controls For use with PTS Panels test strips as quality control materials to estimate 2002.08.21
(glu, chol, HDL, trig) precision and to detect systematic analytical deviations of your test system. »ñÅú
For use with PTS Panels professional test strips as quality control materials 2002.08.21
test system.
»ñÅú
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The A1CNow+ test provides quantitative measurement of glycated
A1CNOW+ TEST KIT haemoglobin levels in capillary (fingerprick) or venous whole blood. This 2009.05.14
an aid to diagnose diabetes and identify patients at risk of developing
»ñÅú
USE)
diabetes.
The A1CNow+ test provides quantitative measurement of glycated
haemoglobin levels in capillary (fingerprick) or venous whole blood. This 2009.05.14
A1CNOW SELF
CHECK
an aid to diagnose diabetes and identify patients at risk of developing
»ñÅú
diabetes.
The A1CNow Self Check test system provides a quantitative measurement
A1CNow Self Check test of the percent of glycated hemoglobin levels in capillary (fingerstick) blood 2009.05.14
system samples. The test is for home use to monitor glycemic control in people with »ñÅú
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
CardioChek Plus used with single-use, auto-disabling lancing devices. This
analyzer system is for in vitro diagnostic use only. The tests strips are 2023.01.1
HDL (high density lipoprotein) cholesterol and triglycerides
IVDR
in venous 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 CHOL+HDL+GLU
PTS PANELS test strips) is for the quantitative determination of total
CHOL+HDL+GLU cholesterol, HDL (high density lipoprotein) cholesterol and 2023.10.0
Test Strips glucose in venous whole blood and capillary whole blood 4 »ñÅú
IVDD 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.
PTS Panels cholesterol test strips are for the quantitative
determination of total cholesterol in venous whole blood and
PTS PANELS
capillary whole blood from the fingertip. Cholesterol 2023.10.0
Cholesterol Test
Strips 4 »ñÅú
disorders involving excess cholesterol in the blood and lipid
IVDD
and lipoprotein metabolism disorders. This system is intended
for professional use.
PTS Panels cholesterol test strips are intended to measure
PTS PANELS total cholesterol in whole blood on a CardioChek Plus
Cholesterol Test analyzer and provide a quantitative result. The results from 2023.04.1
Strips the cholesterol test strip may be used to screen and monitor 1 »ñÅú
IVDR excess cholesterol in the blood and to aid in the diagnosis of
lipid and lipoprotein metabolism disorders.
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The CardioChek Plus glucose test system is intended for the
quantitative determination of glucose in human whole blood
PTS Panels eGLU for use by healthcare professionals. Glucose measurements 2023.10.0
IVDD metabolism disorders including diabetes 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 diagnosis and
PTS PANELS Lipid treatment of disorders involving excess cholesterol in the
IVDD Lipoprotein 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 cholesterol, HDL cholesterol, and triglycerides in whole
PTS PANELS Lipid 2023.04.1
blood on a CardioChek Plus analyzer and provide a
quantitative result. The results from the lipid panel test strip 1 »ñÅú
IVDR
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
Controls 2023.10.0
(glu, chol, HDL, 4 »ñÅú
analytical deviations of your test system.
trig)
The A1CNow+ test provides quantitative measurement of
glycated haemoglobin levels in capillary (fingerprick) or
venous whole blood. This test can be used to monitor 2023.10.0
glycemic control in people with diabetes and as an aid to 4 »ñÅú
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. This test can be used to monitor 2023.10.0
glycemic control in people with diabetes and as an aid to 4 »ñÅú
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 glycemic control in people with diabetes. 2023.10.0
A1C Now+ 4 count Self
OTC Test 4 »ñÅú
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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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 2025 ÄêÄê¶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 2025 ÄêÄê¶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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ÌÑÌÇÍÑÇâø Õæî£ TRUE METRIX ѪÌÇÒÇ¡¢Õæî£ TRUE METRIX AIR ѪÌÇÒÇ
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TRUE METRIX 20182400465 ϸѪ¹ÜȫѪÖÐÆÏÌÑÌǺ¬Á¿¡£±¾²úÆ·Óë TRUE METRIX GO ѪÌÇ
Blood Glucose ÒÇ£¬Õæî£ TRUE METRIX GO ѪÌÇÒÇÅäÌ×ʹÓ㬿ÉÓÃÓÚ¶¨Á¿¼ì²â
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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 2025 ÄêÄê¶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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