Access Total BhCG (Access Total BhCG )
- UID
- IMP/IVD/2019/000053_9040078306eea2a695a80883f027b781_4292bc1aaa8866870d209c17b2d2cdef
- Device class
- Class B
- Brand name
- Access Intact PTH
- License holder
- Beckman Coulter India Private Limited
- 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 veried on the basis of multivariate Gaussian distribution analysis
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.
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.