IVD Department, Quantitative Prolactin Test - Vietnam Registration 240002606/PCBB-HN
Access comprehensive regulatory information for IVD Department, Quantitative Prolactin Test in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002606/PCBB-HN. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI.
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Device Details
Registration Details
240002606/PCBB-HN
000.00.19.H26-240910-0014
Theo theo phụ lục
Theo phụ lục
Technical Details
ARCHITECT Prolactin Calibrators are used to calibrate the ARCHITECT iSystem when quantifying prolactin in human serum and plasma. Refer to the specific ARCHITECT Test Manual for more information. ARCHITECT Prolactin Controls are used to assess the accuracy of the test and to detect systematic analytical deviations of the ARCHITECT iSystem (assay, calibrators, and equipment) when quantifying prolactin in human serum and plasma. Refer to the specific ARCHITECT Test Manual for more information. The ARCHITECT Prolactin Test is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of prolactin in human serum and plasma.
Dates and Status
Oct 02, 2024