Eu Ivdd Eu Ivd General On The Market 🇰🇷 South Korea

CareBuddy HbA1c

CareforU.Co.Ltd · 🇰🇷 South Korea
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
D-8800210900037UW
Basic UDI-DI Code
B-8800210900037UW
Reference
CDC1B02
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market
Manufacturer
CareforU.Co.Ltd

Additional Description

The CareBuddy HbA1c Test Cartridge, together with the CareBuddy Multi Analyzer, which are part of the CareBuddy HbA1c measuring system provides a convenient method for measuring the percent conce ntration of hemoglobin A1c (HbA1c %) in both capillary blood, and whole venous blood. The measurement of hemoglobin A1c concentration is recommended for monitoring the average blood glucose levels, for the long-tern care of people with diabetes. The CareBuddy HbA1c Test Cartridge uses boronate affinity chromatography to separate the glycated hemoglobin fraction from the nonglycated fraction. The CareBuddy HbA1c System is intended to be used by professionals in laboratories, clinics and hospitals.

CND Nomenclature Codes

Code Description
W0101060107 HBA1C TEST STRIPS

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