Vietnam MOH registration 240000447/PCBB-HCM

HHV-8 Protein Qualitative Test Kit

VN: Thuốc thử xét nghiệm định tính protein HHV-8

Vietnam·Risk Class TTBYT Loại B·HHV-8 (13B10) Mouse Monoclonal Antibody·Cell Marque Corporation·Registered Mar 04, 2024

Registration details

Analysis ID: 240000447/PCBB-HCM
Submission ID: 000.00.19.H29-240223-0002
Product Type: HHV-8 (13B10) Mouse Monoclonal Antibody
Product Code: 05269229001

Company information

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

Technical details

Intended Use: HHV-8 Mouse Monoclonal Primary Antibody is used in the laboratory to detect HHV-8 protein on formalin-fixed, paraffin-embedded human tissue sections, by immunohistochemistry (IHC) qualitative analysis on the Benchmark IHC/ISH instrument. This product must be interpreted by a qualified pathologist in conjunction with histology testing, 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 HHV-8 Protein Qualitative Test Kit 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 240000447/PCBB-HCM and manufactured by Cell Marque Corporation. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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