HbA1c Calibrator - India CDSCO Medical Device Registration

HbA1c Calibrator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000023_f724b0c635c1ccb9e2365eb63d047bdb_aa29b0bac4bfdae5e1600574e19c5563. 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 Calibrator

UID: MFG/MD/2018/000023_f724b0c635c1ccb9e2365eb63d047bdb_aa29b0bac4bfdae5e1600574e19c5563

Brand Name

AUTOPAK™

License Holder

Siemens Healthcare Private Limited

Device Class

Class B

Approving Authority

Gujarat

Product Information

AUTOPAK HbA1c CALIBRATOR is designed for use as a calibrator for determination of HbA1c concentration in human blood with immunoturbidimetric method

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CALCIUM- Cyanide Free

Brand: AUTOPAK™

Siemens Healthcare Private Limited

HbA1c Calibrator - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

CALCIUM- Cyanide Free

Protein, pH, Specific Gravity

Protein, pH, Specific Gravity

CHOLINESTERASE

HbA1c

Albumin

Total Protein

LDH Liquid Stable

Direct Bilirubin Vanadate

URIC ACID -Liquid Stable

CALCIUM- Cyanide Free

Protein, pH, Specific Gravity

Protein, pH, Specific Gravity

CHOLINESTERASE

HbA1c

Albumin

Total Protein

LDH Liquid Stable

Direct Bilirubin Vanadate

URIC ACID -Liquid Stable