Estradiol - India CDSCO Medical Device Registration

Estradiol is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000420_a835289dd13d485e6db7ce1db3230843_452927ef7912dfea98059070fe604d2d. This device is marketed under the brand name Electro chemiluminescence Immunoassay. The license holder is M/S Agappe Diagnostics Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Estradiol

UID: IMP/IVD/2021/000420_a835289dd13d485e6db7ce1db3230843_452927ef7912dfea98059070fe604d2d

Brand Name

Electro chemiluminescence Immunoassay

License Holder

M/S Agappe Diagnostics Ltd

Device Class

Class B

Approving Authority

CDSCO

Product Information

Immunoassay for in vitro quantitative determination of 17β-estradiol ( Electro chemiluminescence Immunoassay) in human serum and plasma, which is clinically used for auxiliary diagnosis of ovarian diseases