Vietnam MOH registration 2300646ĐKLH/BYT-HTTB

IVD Department Qualitative Antibody Test for Hepatitis C Virus (HCV)

VN: Bộ IVD xét nghiệm định tính kháng thể kháng virus viêm gan C (HCV)

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Theo theo phụ lục·Registered Jun 20, 2023

Registration details

Analysis ID: 2300646ĐKLH/BYT-HTTB
Submission ID: 18006442/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Theo theo phụ lục
Manufacturer Country: Theo theo phụ lục

Technical details

Intended Use: Alinity s Anti-HCV Calibrators are used to calibrate the Alinity s System when performing qualitative detection of anti-HCV antibodies in human serum and plasma. Alinity s Anti-HCV Assay Controls are used to monitor the calibration of the Alinity s System when performing qualitative detection of anti-HCV antibodies in human serum and plasma. Alinity s Anti-HCV Release Control is used to monitor the functionality of the Alinity s System and to provide the results of the qualitative detection of anti-HCV antibodies in human serum and plasma. Alinity s Anti-HCV is a chemiluminescent microparticle immunoassay (CMIA) used to qualitatively detect anti-HCV antibodies in human serum and plasma, including samples collected for post-mortem examination (no heartbeat) on the Alinity s System. The Alinity s Anti-HCV test is used to support the diagnosis of HCV infection and as a screening test to prevent the transmission of HCV through blood, blood components, cells, tissues, and organs to recipients.

Dates and status

Registration Date: Jun 20, 2023

About this record

Access comprehensive regulatory information for IVD Department Qualitative Antibody Test for Hepatitis C Virus (HCV) in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2300646ĐKLH/BYT-HTTB and manufactured by Theo theo phụ lục.

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