Vietnam MOH registration 240000734/PCBB-HCM

Khay thử xét nghiệm định tính kháng nguyên Giardia

Vietnam·Risk Class TTBYT Loại B·CerTest Giardia+·CERTEST BIOTEC, S.L.·Registered Apr 08, 2024

Registration details

Analysis ID: 240000734/PCBB-HCM
Submission ID: 000.00.19.H29-240304-0018
Product Type: CerTest Giardia+
Product Code: GW820001V

Company information

Manufacturer: CERTEST BIOTEC, S.L.
Product Owner: CERTEST BIOTEC, S.L.
Authorized Representative: CÔNG TY CỔ PHẦN Y TẾ AMVGROUP

Technical details

Intended Use: CerTest Giardia+ is a one-step immunoassay colorimetric test for the qualitative detection of Giardia (α1-giardin and CWP1) in stool samples. CerTest Giardia+ is a simple and highly sensitive screening test for the diagnosis of Giardia infection.

Dates and status

Registration Date: Apr 08, 2024

About this record

Access comprehensive regulatory information for Khay thử xét nghiệm định tính kháng nguyên Giardia 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 240000734/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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