Vietnam MOH registration 220002697/PCBB-BYT

Qualitative Antibody Test for IgG against EBNA

VN: Bộ xét nghiệm định tính kháng thể IgG kháng EBNA

Vietnam·Risk Class TTBYT Loại B·VIDAS EBV EBNA IgG·BIOMERIEUX SA·Registered Jul 15, 2022

Registration details

Analysis ID: 220002697/PCBB-BYT
Submission ID: 000.00.04.G18-220715-0026
Product Type: VIDAS EBV EBNA IgG
Product Code: 30235

Company information

Manufacturer: BIOMERIEUX SA
Manufacturer Country: 69280 Marcy L'Etoile

Technical details

Intended Use: VIDAS EBV EBNA IgG is an automated test performed on the VIDAS system, detecting IgG antibodies against EBNA (a protein of the Epstein-Barr virus) in human serum samples using the ELFA (Enzyme-Linked Fluorescent Assay) technique. The detection of specific antibodies aids in the diagnosis of Chronic Myelomonocytic Leukemia (CMML).

Dates and status

Registration Date: Jul 15, 2022

About this record

Access comprehensive regulatory information for Qualitative Antibody Test for IgG against EBNA 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 220002697/PCBB-BYT and manufactured by BIOMERIEUX SA.

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