Vietnam MOH registration 2402921ĐKLH/BYT-HTTB

Khay thử xét nghiệm định tính kháng nguyên Malaria P.f/P.v

Vietnam·Risk Class TTBYT Loại C·Malaria P.f/P.v Antigen Rapid Test Cassette (Whole Blood)·Acon Biotech (Hangzhou) Co., Ltd.·Registered Oct 22, 2024

Registration details

Analysis ID: 2402921ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-221101-0009
Product Type: Malaria P.f/P.v Antigen Rapid Test Cassette (Whole Blood)
Product Code: L031-11011

Company information

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer Country: CHINA
Authorized Representative: CÔNG TY CỔ PHẦN Á CHÂU

Technical details

Intended Use: Malaria P.f/P.v Antigen Rapid Test Cassette (Whole Blood) is an immunochromatographic test for qualitative detection of Histidine-Rich Protein II (HRP-II) specific to Plasmodium falciparum (P.f) and Plasmodium lactate dehydrogenase (pLDH) specific to Plasmodium vivax (P.v) in whole blood.

Dates and status

Registration Date: Oct 22, 2024

About this record

Access comprehensive regulatory information for Khay thử xét nghiệm định tính kháng nguyên Malaria P.f/P.v 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 2402921ĐKLH/BYT-HTTB and manufactured by Acon Biotech (Hangzhou) Co., Ltd.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN Á CHÂU.

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