Vietnam MOH registration 240000733/PCBB-HCM

Qualitative Strep A Antigen Test Kit

VN: Que thử/Khay thử xét nghiệm định tính kháng nguyên Strep A

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·CERTEST BIOTEC, S.L.·Registered Apr 08, 2024

Registration details

Analysis ID: 240000733/PCBB-HCM
Submission ID: 000.00.19.H29-240305-0005
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: CERTEST BIOTEC, S.L.
Manufacturer Country: Theo theo phụ lục
Product Owner: CERTEST BIOTEC, S.L.
Authorized Representative: CÔNG TY CỔ PHẦN Y TẾ AMVGROUP

Technical details

Intended Use: Product Code: T720201PC: The CerTest Strep A qualitative immuno-chromatographic test strip is a colorimetric immunoassay technique for the qualitative detection of Streptococcal group A from throat swab samples and culture isolates when Streptococcal group A is suspected. The CerTest Strep A qualitative immuno-chromatographic test strip is a simple and highly sensitive screening test used to diagnose streptococcal group A pharyngitis based on a sound scientific basis. Product Code: T820201PC: The CerTest Strep A qualitative immuno-chromatographic test strip is a colorimetric immunoassay technique for the qualitative detection of Streptococcal group A from throat swab samples and culture isolates when Streptococcal group A is suspected. The CerTest Strep A qualitative immuno-chromatographic test strip is a simple and highly sensitive screening test used in the diagnosis of streptococcal group A pharyngitis based on a sound scientific basis.

Dates and status

Registration Date: Apr 08, 2024

About this record

Access comprehensive regulatory information for Qualitative Strep A Antigen Test Kit 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 240000733/PCBB-HCM and manufactured by CERTEST BIOTEC, S.L.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN Y TẾ AMVGROUP.

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