AMH - India CDSCO Medical Device Registration

AMH is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000028_df26fc73fafd026606169512f50de28f_ee13e3ba0ad9b187c2c2532d12285416. This device is marketed under the brand name MAGLUMI. The license holder is Vector Biotek 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

AMH

UID: IMP/IVD/2021/000028_df26fc73fafd026606169512f50de28f_ee13e3ba0ad9b187c2c2532d12285416

Brand Name

MAGLUMI

License Holder

Vector Biotek Pvt Ltd

Device Class

Class B

Approving Authority

CDSCO

Product Information

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Anti-Mullerian Hormone (MAGLUMI) in human serum with the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer