IVD Immunology Testing Cluster - Vietnam Registration 240000156/PCBB-HN
Access comprehensive regulatory information for IVD Immunology Testing Cluster in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240000156/PCBB-HN and manufactured by Shenzhen Drawray Biotech Co., Ltd. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI DỊCH VỤ TRÍ VIỆT PHÁT.
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Device Details
Registration Details
240000156/PCBB-HN
000.00.19.H26-240115-0031
Theo theo phụ lục
Theo phụ lục
Technical Details
iStar-AMH: iStar-AMH is a CLIA (Chemiluminescent Immunoassay) test to quantify the concentration of Anti-Müllerian Hormone (AMH) in the blood and serum of individuals suspected of having abnormal ovarian reserve, as determined by the iStar automated chemiluminescent immunoassay machine. The iStar-AMH test is used by clinical laboratories as a supportive tool for evaluating ovarian reserve, in conjunction with other clinical methods. iStar-Inhibin B: iStar-Inhibin B is a CLIA (Chemiluminescent Immunoassay) test to quantify Inhibin B in the blood and serum of individuals suspected of having reproductive disorders, as determined by the iStar automated chemiluminescent immunoassay machine. The iStar-Inhibin B test is used by clinical laboratories as a supportive tool for evaluating male fertility and testicular function, and female ovarian reserve, in conjunction with other clinical methods. iStar-hGH: iStar-hGH is a CLIA (Chemiluminescent Immunoassay) test to quantify in vitro the concentration of Human Growth Hormone (hGH) in the blood and serum of individuals. The iStar-hGH test is used by clinical laboratories as a supportive tool for diagnosing and treating various forms of abnormal hormone secretion, in conjunction with other clinical methods. iStar-CHI3L1: iStar-CHI3L1 is a CLIA (Chemiluminescent Immunoassay) test to quantify Chitinase 3-like protein 1 (CHI3L1) in the blood of individuals, as determined by the iStar automated chemiluminescent immunoassay machine. The iStar-CHI3L1 test is used by clinical laboratories as a supportive tool for diagnosing patients with liver cirrhosis, in conjunction with other clinical methods. iStar-Gastrin-17: iStar-Gastrin-17 is a CLIA (Chemiluminescent Immunoassay) test to quantify Gastrin-17 (G-17) in the blood and serum of individuals suspected of having chronic atrophic gastritis, as determined by the iStar automated chemiluminescent immunoassay machine. The iStar-Gastrin-17 test is used by clinical laboratories as a supportive tool for diagnosing chronic atrophic gastritis, in conjunction with other clinical methods.
Dates and Status
Jan 23, 2024