Access Total BhCG (Access Total BhCG ) - India CDSCO Medical Device Registration

Access Total BhCG (Access Total BhCG ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000053_9040078306eea2a695a80883f027b781_4292bc1aaa8866870d209c17b2d2cdef. 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 Total BhCG (Access Total BhCG )

UID: IMP/IVD/2019/000053_9040078306eea2a695a80883f027b781_4292bc1aaa8866870d209c17b2d2cdef

Brand Name

Access Intact PTH

License Holder

Beckman Coulter India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Access Total βhCG (Access Intact PTH) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total βhCG levels in human serum and plasma using the Access Immunoassay Systems. This assay is intended for use as an aid in the early detection of pregnancy. The concentration of βhCG determined by this kit can also be used in conjunction with AFP, unconjugated estriol, and Inhibin A concentrations in Down syndrome (Access Intact PTH) risk assessment. Such an approach has been veried on the basis of multivariate Gaussian distribution analysis