Access Total BhCG (Access Total BhCG )-The Access Total BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG 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 BhCG determined by this kit can also be used in conjunction with AFP, unconjugated estriol, and Inhibin A concentrations in Down syndrome risk assessment. Such an approach has been verified on the basis of multivariate Gaussian distribution analysis.,ß-2 MICROGLOBULIN
- UID
- IMP/IVD/2019/000040_ded68478c290adfed82a6b0448c71e9f_ee1d402d6224ec575602f7fde26cbf8d
- Device class
- Class B
- Brand name
- COULTER LH Series Pak Reagent Kit
- License holder
- Beckman Coulter India Private Limited
- Approving authority
- CDSCO
- Product information
- Immuno-turbidimetric test for the quantitative determination of beta-2 microglobulin in human serum and plasma on Beckman Coulter AU analysers
Access Total BhCG (Access Total BhCG )-The Access Total BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG 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 BhCG determined by this kit can also be used in conjunction with AFP, unconjugated estriol, and Inhibin A concentrations in Down syndrome risk assessment. Such an approach has been verified on the basis of multivariate Gaussian distribution analysis.,ß-2 MICROGLOBULIN is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000040_ded68478c290adfed82a6b0448c71e9f_ee1d402d6224ec575602f7fde26cbf8d. This device is marketed under the brand name COULTER LH Series Pak Reagent Kit. 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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