Vietnam MOH registration 2403393ĐKLH/BYT-HTTB

IVD Department Qualitative IgM Antibody Test for SARS-CoV-2

VN: Bộ IVD xét nghiệm định tính kháng thể IgM kháng SARS-CoV-2

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Beckman Coulter, Inc.·Registered Nov 06, 2024

Registration details

Analysis ID: 2403393ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230822-0009
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Beckman Coulter, Inc.
Manufacturer Country: Theo theo phụ lục
Product Owner: Beckman Coulter, Inc.
Authorized Representative: CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG

Technical details

Intended Use: 1. Access SARS-CoV-2 IgM is a fluorescent bead-based immunoassay for the qualitative detection of IgM antibodies against SARS-CoV-2 in human serum, plasma and blood (anticoagulated with EDTA, citrate and heparin) on the Access Immunoassay System. When combined with clinical presentation and other laboratory tests in the laboratory, Access SARS-CoV-2 IgM supports the diagnosis of SARS-CoV-2 infection and helps identify patients with an immune response to SARS-CoV-2, indicating recent primary infection or prior infection. The result of the Access SARS-CoV-2 IgM test should not be used as the sole basis for diagnosing SARS-CoV-2 infection. 2. Access SARS-CoV-2 IgM Calibrator is used to calibrate the Access SARS-CoV-2 IgM test, the qualitative in vitro immunoassay for the detection of IgM antibodies against SARS-CoV-2 in human serum, plasma and blood (anticoagulated with heparin, EDTA and citrate), and is only intended for use on the Access Immunoassay System. 3. Access SARS-CoV-2 IgM QC is used to monitor the performance of the Access SARS-CoV-2 IgM test. Access SARS-CoV-2 IgM QC is only intended for use on the Access Immunoassay System.

Dates and status

Registration Date: Nov 06, 2024

About this record

Access comprehensive regulatory information for IVD Department Qualitative IgM Antibody Test for SARS-CoV-2 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 2403393ĐKLH/BYT-HTTB and manufactured by Beckman Coulter, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG.

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