Vietnam MOH registration 240001394/PCBB-HCM

IVD Parasite Infection - Immune

VN: Cụm IVD Nhiễm ký sinh trùng - miễn dịch

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Acro Biotech, Inc.·Registered Jul 08, 2024

Registration details

Analysis ID: 240001394/PCBB-HCM
Submission ID: 000.00.19.H29-240626-0007
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Acro Biotech, Inc.
Manufacturer Country: Theo theo phụ lục
Product Owner: Acro Biotech, Inc.
Authorized Representative: CÔNG TY TNHH THƯƠNG MẠI Y TẾ PHÚ GIA

Technical details

Intended Use: 1. Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is an immunochromatographic rapid test for the qualitative detection of Leishmania-specific IgG and IgM antibodies in whole blood, serum, or plasma. 2. Filariasis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is an immunochromatographic rapid test for the qualitative detection of IgG and IgM antibodies against the filarial parasites W. Bancrofti and B. Malayi in whole blood, serum, or plasma, to aid in the diagnosis of filariasis. 3. Filariasis IgG/IgM Rapid Test Cassette (Serum/Plasma) is an immunochromatographic rapid test for the qualitative detection of IgG and IgM antibodies against the filarial parasites W. Bancrofti and B. Malayi in serum or plasma, to aid in the diagnosis of filariasis.

Dates and status

Registration Date: Jul 08, 2024

About this record

Access comprehensive regulatory information for IVD Parasite Infection - Immune 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 240001394/PCBB-HCM and manufactured by Acro Biotech, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI Y TẾ PHÚ GIA.

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