AMH Rapid Quantitative Test - India CDSCO Medical Device Registration

AMH Rapid Quantitative Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000164_17f7b96ee8e089459c1b11fdab28d0ba_0b8005f0ff89db1e8053cea6c3d6e40f. This device is marketed under the brand name E2. The license holder is M/s Avantor Performance Materials India Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

AMH Rapid Quantitative Test

UID: IMP/IVD/2022/000164_17f7b96ee8e089459c1b11fdab28d0ba_0b8005f0ff89db1e8053cea6c3d6e40f

Brand Name

License Holder

M/s Avantor Performance Materials India Ltd

Device Class

Class B

Approving Authority

CDSCO

Product Information

AMH Rapid Quantitative Test is a fluorescence immunoassay used along with FinecareTM FIA Meters (E2) for quantitative measurement of AMH in human whole blood, serum or plasma. The test is mainly used in the assessment of the ovarian reserve and as an aid in the diagnosis of polycystic ovary syndrome (E2)