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The GLUCO-CARE® HS100 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly).
Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effective- ness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.
The GLUCO-CARE® HS100 Blood Glucose Monitoring System is comprised of the GLUCO-CARE® HS100 Blood Glucose Meter and GLUCO-CARE® HS100 Blood Glucose Test Strip.
MediVena, LLC
HS100
In Commercial Distribution
- 00810008217528 ()
- 00810008217511 ()
4013
- Glucose monitoring system IVD, home-use
- Glucose monitoring system IVD, point-of-care
The GLUCO-CARE® HS100 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effective-ness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or
for neonatal use.
The GLUCO-CARE® HS100 Blood Glucose Monitoring System is comprised of the GLUCO-CARE® HS100 Blood Glucose Meter and GLUCO-CARE® HS100 Blood Glucose Test Strip.
MediVena, LLC
HS100
In Commercial Distribution
- 00810008217504 ()
- 00810008217498 ()
4011
- Glucose monitoring system IVD, home-use
- Glucose monitoring system IVD, point-of-care
GLUCO-CARE test strips are intended for use with GLUCO-CARE glucose meters for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effective-ness of diabetes control. It should only be used by a single patient and it should
not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.
The GLUCO-CARE® HS100 Blood Glucose Monitoring System is comprised of the GLUCO-CARE® HS100 Blood Glucose Meter and GLUCO-CARE® HS100 Blood Glucose Test Strip.
MediVena, LLC
HS100
In Commercial Distribution
- 00810008215579 ()
- 00810008215562 ()
- 00810008215586 ()
4012
- Glucose monitoring system IVD, home-use
- Glucose monitoring system IVD, point-of-care
ONE-CARE test strips are intended for use with ONE-CARE glucose meters for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). ONE-CARE system can be used at home (over the counter OTC) by persons with diabetes. Test strips require small blood samples size of 0.5ul to provide accurate and fast results within 5 seconds. The system is based on auto-coding technology and no programming is needed when using new batch of test strips.
MediVena, LLC
AC500
In Commercial Distribution
- 00810008210512 ()
- 00810008210369 ()
- 00810008210529 ()
4007
- Glucose monitoring system IVD, home-use
ONE-CARE glucose monitoring system is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). ONE-CARE system can be used at home (over the counter OTC) by persons with diabetes. ONE-CARE glucose meter feature strip ejector for safe removal of used strip, large and user-friendly display, as well as small blood samples size of 0.5ul to provide accurate and fast results within 5 seconds. The system is based on auto-coding technology and no programming is needed when using new batch of test strips. ONE-CARE glucose monitor automatically powers on and shuts down when the strip is inserted/ejected.
MediVena, LLC
AC500
In Commercial Distribution
- 00810008210451 ()
- 00810008210161 ()
4006
- Glucose monitoring system IVD, home-use
ONE-CARE PRO test strips are intended for use with ONE-CARE PRO glucose meters for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). ONE-CARE PRO system can be used by healthcare professionals in multi-patient setting. Test strips require small blood samples size of 0.5ul to provide accurate and fast results within 5 seconds. The system is based on auto-coding technology and no programming is needed when using new batch of test strips.
MediVena, LLC
AC500 PRO
In Commercial Distribution
- 00810008210499 ()
- 00810008210048 ()
- 00810008210505 ()
4002
- Glucose monitoring system IVD, home-use
- Glucose monitoring system IVD, point-of-care
ONE-CARE PRO glucose monitoring system is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). ONE-CARE PRO system can be used by healthcare professionals in multi-patient setting. ONE-CARE PRO glucose meter feature strip ejector for convenient removal of used strip, large and user-friendly display, as well as small blood samples size of 0.5ul to provide test results within 5 seconds. The system is based on auto-coding technology and no programming is needed when using new batch of test strips. ONE-CARE PRO glucose meter automatically powers on and shuts down when the strip is inserted/ejected.
MediVena, LLC
AC500 PRO
In Commercial Distribution
- 00810008210031 ()
- 00810008210406 ()
4001
- Glucose monitoring system IVD, home-use
- Glucose monitoring system IVD, point-of-care
Syntron QuikStrip Pregnancy Test
SYNTRON BIORESEARCH, INC.
9010
In Commercial Distribution
- 10748349000394 ()
- 00748349000397 ()
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
QuikStrip OneStep hCG Test
SYNTRON BIORESEARCH, INC.
9020
In Commercial Distribution
- 10748349000233 ()
- 00748349000236 ()
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
QuikStrip OneStep hCG 5mm
SYNTRON BIORESEARCH, INC.
9010-5
In Commercial Distribution
- 10748349000097 ()
- 00748349000090 ()
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical