Vietnam MOH registration 2401164ĐKLH/BYT-HTTB

CA 19-9 Quantitative Testing Reagent

VN: Thuốc thử xét nghiệm định lượng CA 19-9
Vietnam flagVietnam·Risk Class TTBYT Loại C·Elecsys CA 19-9·Roche Diagnostics (Suzhou) Ltd.·Registered Jul 22, 2024
Registration details
Analysis ID
2401164ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-230921-0029
Product Type
Elecsys CA 19-9
Product Code
07027028214
Company information
Manufacturer Country
CHINA
Authorized Representative
CÔNG TY TNHH ROCHE VIỆT NAM
Technical details
Intended Use
In vitro immunoassay for the quantitative determination of CA 19-9 in human serum and plasma. The ECLIA (electrochemiluminescence immunoassay “ECLIA”) is used in the cobas e immunoassay system.
Dates and status
Registration Date
Jul 22, 2024
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About this record

Access comprehensive regulatory information for CA 19-9 Quantitative Testing Reagent in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2401164ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics (Suzhou) Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Roche Diagnostics (Suzhou) Ltd., and 1 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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