Vietnam MOH registration 240000813/PCBB-HCM

Specific Immunodetection Quantitative Testing Control Material

VN: Vật liệu kiểm soát xét nghiệm định lượng miễn dịch đặc hiệu

Immunoassay Speciality II – Level 1 (IA Speciality II Lev 1); Immunoassay Speciality II – Level 2 (IA Speciality II Lev 2); Immunoassay Speciality II – Level 3 (IA Speciality II Lev 3)

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Randox Laboratories Ltd·Registered Apr 16, 2024

Registration details

Analysis ID: 240000813/PCBB-HCM
Submission ID: 000.00.19.H29-240409-0014
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Randox Laboratories Ltd
Manufacturer Country: Theo theo phụ lục
Product Owner: Randox Laboratories Ltd
Authorized Representative: CÔNG TY TNHH TRANG THIẾT BỊ Y TẾ TRẦN DANH

Technical details

Intended Use: This product is designed for in vitro diagnostic use, to help control the accuracy quality of the clinical immunology test system. The material can be used to monitor and control the accuracy or reproducibility of the immunology tests.

Dates and status

Registration Date: Apr 16, 2024

About this record

Access comprehensive regulatory information for Specific Immunodetection Quantitative Testing Control Material 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 240000813/PCBB-HCM and manufactured by Randox Laboratories Ltd. The authorized representative in Vietnam is CÔNG TY TNHH TRANG THIẾT BỊ Y TẾ TRẦN DANH.

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