Direct HbA1c - India CDSCO Medical Device Registration

Direct HbA1c is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000130_f04b6c3a0b9bc0c7c6e1c280b30cfed5_d77fc00a1e9ddee77e2a208f08e7bc6b. This device is marketed under the brand name serum Proteins Calibrator. The license holder is Labtech Health Care India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Direct HbA1c

UID: IMP/IVD/2022/000130_f04b6c3a0b9bc0c7c6e1c280b30cfed5_d77fc00a1e9ddee77e2a208f08e7bc6b

Brand Name

serum Proteins Calibrator

License Holder

Labtech Health Care India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

Quantitative determination of glycated hemoglobin (serum Proteins Calibrator) in human blood

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BILIRUBIN T&D –DMSO

Brand: serum Proteins Calibrator

Labtech Health Care India Pvt. Ltd.

Direct HbA1c - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

BILIRUBIN T&D –DMSO

Sheath reagent for Spincell 5 Series(Sheath reagent for Spincell 5 Series)

CREATININE -J

IgM (IgM )

Albumin

IgG (IgG )

Pre-albumin

Direct Bilirubin - DPD

Serum Proteins Calibrator

SPINCHEM 2 Human Control serum

HbA1c Calibrator

HbA1c Reagent Kit (HbA1c Reagent Kit )

HbA1c Analyzer(HbA1c Analyzer )

HbA1c Control Material

BILIRUBIN T&D –DMSO

Sheath reagent for Spincell 5 Series(Sheath reagent for Spincell 5 Series)

CREATININE -J

IgM (IgM )

Albumin

IgG (IgG )