IVD Department, Quantitative Pepsinogen II Test - Vietnam Registration 220002548/PCBB-BYT
Access comprehensive regulatory information for IVD Department, Quantitative Pepsinogen II Test 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 220002548/PCBB-BYT and manufactured by Theo theo phụ lục.
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Device Details
Registration Details
220002548/PCBB-BYT
000.00.04.G18-220622-0010
Theo theo phụ lục
Theo phụ lục
Technical Details
The ARCHITECT Pepsinogen II Calibration Standard is used to calibrate the ARCHITECT iSystem when quantifying pepsinogen II in human serum and plasma. The ARCHITECT Pepsinogen II Controls are used to assess the accuracy of the test and to detect systematic analytical errors in the ARCHITECT iSystem when quantifying pepsinogen II in human serum and plasma. ARCHITECT Pepsinogen II (PG II) is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of pepsinogen II in human serum and plasma.
Dates and Status
Jun 22, 2022