Vietnam MOH registration 240000881/PCBB-HCM

CD163 qualitative protein test

VN: Thuốc thử xét nghiệm định tính protein CD163

Vietnam·Risk Class TTBYT Loại B·CD163 (MRQ-26) Mouse Monoclonal Antibody·Cell Marque Corporation·Registered Apr 26, 2024

Registration details

Analysis ID: 240000881/PCBB-HCM
Submission ID: 000.00.19.H29-240411-0038
Product Type: CD163 (MRQ-26) Mouse Monoclonal Antibody
Product Code: 05973929001

Company information

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

Technical details

Intended Use: CD163 (MRQ-26) Mouse Monoclonal Primary Antibody is used in the laboratory to detect CD163 protein on formalin-fixed, paraffin-embedded human tissue sections by immunohistochemistry (IHC) on the BenchMark IHC/ISH instrument. This product must be interpreted by a qualified pathologist in conjunction with histology, relevant clinical information, and appropriate positive control samples. The antibody is intended for in vitro diagnostic use (IVD).

Dates and status

Registration Date: Apr 26, 2024

About this record

Access comprehensive regulatory information for CD163 qualitative protein test 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 240000881/PCBB-HCM and manufactured by Cell Marque Corporation. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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