Vietnam MOH registration 220002133/PCBB-BYT

Amylase Quantitative Testing Drug

VN: Thuốc thử xét nghiệm định lượng amylase
Vietnam flagVietnam·Risk Class TTBYT Loại B·Amylase2·Abbott Ireland Diagnostics Division·Registered Apr 27, 2022
Registration details
Analysis ID
220002133/PCBB-BYT
Submission ID
000.00.04.G18-220427-0008
Product Type
Amylase2
Company information
Manufacturer Country
Ireland
Technical details
Intended Use
Amylase2 testing is used to quantify amylase in human serum, plasma, or urine on the ARCHITECT c Systems. Amylase2 testing is primarily used to support the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
Dates and status
Registration Date
Apr 27, 2022
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About this record

Access comprehensive regulatory information for Amylase Quantitative Testing Drug 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 220002133/PCBB-BYT and manufactured by Abbott Ireland Diagnostics Division.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Abbott Ireland Diagnostics Division, 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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