Dehydroepiandrosterone Sulfate Tracer - India CDSCO Medical Device Registration

Dehydroepiandrosterone Sulfate Tracer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000039_ff7b13aabb21330cfaf71c0310692fa7_ac2d4862be4a7dc4a64c385dd889936c. This device is marketed under the brand name HbA1c. The license holder is Tosoh India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is Kokan Division.

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CDSCO Registered

Class Class B

Dehydroepiandrosterone Sulfate Tracer

UID: MFG/IVD/2021/000039_ff7b13aabb21330cfaf71c0310692fa7_ac2d4862be4a7dc4a64c385dd889936c

Brand Name

HbA1c

License Holder

Tosoh India Pvt. Ltd.

Device Class

Class B

Approving Authority

Kokan Division

Product Information

For in-vitro diagnostic use only for quantitative determination of DHEA-S antibodies in Human Serum by a Microplate Enzyme Immunoassay, Chemiluminescence method