Vietnam MOH registration 2400162ĐKLH/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 Feb 04, 2024
Registration details
Analysis ID
2400162ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-221207-0021
Product Type
Elecsys CA 19-9
Product Code
11776193214
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) is used in Elecsys and cobas e immunoassay analyzers.
Dates and status
Registration Date
Feb 04, 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 2400162ĐKLH/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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