Access SHBG - India CDSCO Medical Device Registration

Access SHBG is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000053_947fb2af1f1c7d481a80c511002b9d84_71a7feea6c9a12f8913b4a87c53cd911. This device is marketed under the brand name Access Intact PTH. The license holder is Beckman Coulter India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Access SHBG

UID: IMP/IVD/2019/000053_947fb2af1f1c7d481a80c511002b9d84_71a7feea6c9a12f8913b4a87c53cd911

Brand Name

Access Intact PTH

License Holder

Beckman Coulter India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems

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