HbA1c - India CDSCO Medical Device Registration

HbA1c is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000241_f0db786141f00b78e5b1a8873c63a7ff_fdb58d4dcdd78b17a8b73904bd77229a. This device is marketed under the brand name Elitech Clinical Systems SAS. The license holder is Q-Line Biotech Private Limited (Formerly Known As POCT SERVICES PRIVATE LIMITED), and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

HbA1c

UID: IMP/IVD/2022/000241_f0db786141f00b78e5b1a8873c63a7ff_fdb58d4dcdd78b17a8b73904bd77229a

Brand Name

Elitech Clinical Systems SAS

License Holder

Q-Line Biotech Private Limited (Formerly Known As POCT SERVICES PRIVATE LIMITED)

Device Class

Class B

Approving Authority

CDSCO

Product Information

Elitech Clinical Systems HbA1c reagent is intended for the quantitative in vitro diagnostic determination of hemoglobin A1c(Elitech Clinical Systems SAS) in human whole blood

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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

HbA1c

HbA1c

HbA1c

HbA1c

HbA1c

ISE Diluent

Acid Solution

ALP SL

ELITROL I

ISE Diluent

Acid Solution

ALP SL

ELITROL I

GLUCOSE PAP SL

Albumin

Phosphorus

Triglycerides Mono SL New

ALT/GPT 4+1 SL

System Solution