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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-
Multi-monitoring
System testing at home by people as an aid for monitoring the effectiveness 2026.05.22 »ñµÃ
(model: KUG-11, of diabetes and hyperuricement (HUA) control. Only professionals CE ÈÏÖ¤
KUG-12)
may test neonatal, arterial and 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 Sinocare uric acid control solution is for use only with Uric
Acid Meter or Multi-monitoring Meter and Uric Acid test strip
Sinocare Uric Acid
Control Solution
C produced by Sinocare to check that the meter and strip are working
together properly and the test is performing correctly. It is for self-
testing or near-patient testing. 2026.05.18 »ñµÃ
The Sinocare blood ketone control solution is for use only with CE ÈÏÖ¤
Sinocare Blood Multi-monitoring Meter and Blood Ketone test strip produced by
Ketone Control C Sinocare to check that they are working together properly and that
Solution the test is performing correctly. It is for self-testing or near-patient
testing.
The Safe AQ 8000 Multi-monitoring System is intended for use in the
quantitative measurement of glucose in fresh
Multi-monitoring capillary/venous/arterial/neonatal whole blood, the uric acid and the blood 2026.06.18 »ñµÃ
Analyzer ketone in fresh capillary/venous whole blood. It is intended to be used for CE ×ÔÎÒÐû³Æ
near-patient testing by healthcare professionals as an aid for monitoring the
effectiveness of diabetes and hyperuricemia(HUA) control.
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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.
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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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FDA ×¢²áÖ¤ºÍ 11 ÏîÓÐЧµÄ CE ÈÏÖ¤Ö¤Ê飬¾ßÌåÃ÷ϸÈçÏ£º
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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 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
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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
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diabetes and as an aid to diagnose diabetes and identify patients at risk
of developing diabetes.
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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
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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
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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
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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
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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
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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
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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
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(glu, chol, HDL, test system.
trig)
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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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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.
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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.
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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.
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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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ÆäËûÒµÎñ 2,694,747.15 394,796.88 4,799,455.79 587,942.76
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