HbA1c - India CDSCO Medical Device Registration

HbA1c is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000023_f0db786141f00b78e5b1a8873c63a7ff_af10d55f3369ad9de19276b8ac98bf59. This device is marketed under the brand name AUTOPAK™. The license holder is Siemens Healthcare Private Limited, and it is classified as Device Class Class B. The approving authority is Gujarat.

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CDSCO Registered

Class Class B

HbA1c

UID: MFG/MD/2018/000023_f0db786141f00b78e5b1a8873c63a7ff_af10d55f3369ad9de19276b8ac98bf59

Brand Name

AUTOPAK™

License Holder

Siemens Healthcare Private Limited

Device Class

Class B

Approving Authority

Gujarat

Product Information

For In vitro diagnostic use in the quantitative measurement of HbA1c concentration in human whole blood using clinical chemistry analyzer

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HbA1c

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HbA1c - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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HbA1c

CALCIUM- Cyanide Free

Protein, pH, Specific Gravity

Protein, pH, Specific Gravity

CHOLINESTERASE

HbA1c Calibrator

Albumin

Total Protein

LDH Liquid Stable

Direct Bilirubin Vanadate

CALCIUM- Cyanide Free

Protein, pH, Specific Gravity

Protein, pH, Specific Gravity

CHOLINESTERASE

HbA1c Calibrator

Albumin

Total Protein

LDH Liquid Stable

Direct Bilirubin Vanadate

URIC ACID -Liquid Stable