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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/2021/000413_5338e56adfe6768a730930dfde597a36_97feb4c0835795788d27a343d41fcc89. This device is marketed under the brand name Finecare Beta-HCG Rapid Quantitative Test. The license holder is Star Biomed Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class B
AMH Test
UID: IMP/IVD/2021/000413_5338e56adfe6768a730930dfde597a36_97feb4c0835795788d27a343d41fcc89

Brand Name

Finecare Beta-HCG Rapid Quantitative Test

License Holder

Star Biomed Pvt. Ltd.

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 (Finecare Beta-HCG 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 (Finecare Beta-HCG Rapid Quantitative Test)

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