Vietnam MOH registration 220002548/PCBB-BYT

IVD Department, Quantitative Pepsinogen II Test

VN: Bộ IVD xét nghiệm định lượng Pepsinogen II
Vietnam flagVietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered Jun 22, 2022
Registration details
Analysis ID
220002548/PCBB-BYT
Submission ID
000.00.04.G18-220622-0010
Product Type
Theo theo phụ lục
Product Code
Theo phụ lục
Company information
Manufacturer Country
Theo theo phụ lục
Technical details
Intended Use
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
Registration Date
Jun 22, 2022
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About this record

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.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Abbott GmbH, and 2 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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