Vietnam MOH registration 2403201ĐKLH/BYT-HTTB

Khay thử xét nghiệm định tính kháng nguyên vi rút cúm A, cúm B

Vietnam flagVietnam·Risk Class TTBYT Loại C·CerTest Influenza A+B·CERTEST BIOTEC, S.L.·Registered Nov 02, 2024
Registration details
Analysis ID
2403201ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-201219-0001
Product Type
CerTest Influenza A+B
Product Code
Z882001PC
Company information
Manufacturer Country
SPAIN
Product Owner
CERTEST BIOTEC, S.L.
Authorized Representative
CÔNG TY CỔ PHẦN Y TẾ AMVGROUP
Technical details
Intended Use
The 1-step strip test CerTest Influenza A+B is a colorimetric immunoassay technique for the qualitative detection of both Influenza A and B types simultaneously from nasal swab samples, aspirate samples, or tracheal wash samples. CerTest Influenza A+B is a simple technique and serves as a high-sensitivity screening test to aid in the diagnosis of respiratory tract infections caused by Influenza A and/or Influenza B types.
Dates and status
Registration Date
Nov 02, 2024
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About this record

Access comprehensive regulatory information for Khay thử xét nghiệm định tính kháng nguyên vi rút cúm A, cúm B 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 2403201ĐKLH/BYT-HTTB and manufactured by CERTEST BIOTEC, S.L.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN Y TẾ AMVGROUP.

This page provides complete technical specifications, regulatory compliance details, 3 companies making similar products including SD Biosensor, Inc., Biopanda Reagent Ltd., and 3 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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