Vietnam MOH registration 240000445/PCBB-HCM

Qualitative Viral Testing for Herpes Simplex I

VN: Thuốc thử xét nghiệm định tính Vi rút Herpes Simplex I

Vietnam·Risk Class TTBYT Loại B·Herpes Simplex Virus 1 (10A3) Mouse Monoclonal Primary Antibody·Cell Marque Corporation·Registered Mar 04, 2024

Registration details

Analysis ID: 240000445/PCBB-HCM
Submission ID: 000.00.19.H29-240227-0036
Product Type: Herpes Simplex Virus 1 (10A3) Mouse Monoclonal Primary Antibody
Product Code: 07047746001

Company information

Manufacturer: Cell Marque Corporation
Product Owner: Cell Marque Corporation
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: Herpes Simplex Virus I (10A3) Mouse Monoclonal Primary Antibody is used in the laboratory to detect Herpes Simplex I virus on formalin-fixed, paraffin-embedded human tissue sections, and is analyzed qualitatively on the BenchMark IHC/ISH instrument. The product must be interpreted by a qualified pathologist in conjunction with histology, relevant clinical information, and appropriate control material (positive control). This antibody is intended for in vitro diagnostic use (IVD).

Dates and status

Registration Date: Mar 04, 2024

About this record

Access comprehensive regulatory information for Qualitative Viral Testing for Herpes Simplex I 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 240000445/PCBB-HCM and manufactured by Cell Marque Corporation. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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