AMH Test - India CDSCO Medical Device Registration

AMH Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000191_5338e56adfe6768a730930dfde597a36_b4bd48b366d7fa8e57a443edc893f3cf. This device is marketed under the brand name Testosterone Rapid Quantitative Test. The license holder is Matrix Labs, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

AMH Test

UID: IMP/IVD/2019/000191_5338e56adfe6768a730930dfde597a36_b4bd48b366d7fa8e57a443edc893f3cf

Brand Name

Testosterone Rapid Quantitative Test

License Holder

Matrix Labs

Device Class

Class B

Approving Authority

CDSCO

Product Information

The FinecareTM AMH Rapid Quantitative Test is a fluorescence immunoassay used along with FinecareTM FIA Meters (Testosterone Rapid Quantitative Test) 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 (Testosterone Rapid Quantitative Test)