Vietnam MOH registration 240000812/PCBB-HCM

Standard calibration reagent for biochemical quantitative testing

VN: Chất hiệu chuẩn xét nghiệm định lượng sinh hóa

Calibration Serum Level 2 (CAL 2), Calibration Serum Level 3 (CAL 3)

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

Registration details

Analysis ID: 240000812/PCBB-HCM
Submission ID: 000.00.19.H29-240405-0022
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 used as a calibration standard in biochemical testing. The product is based on the dried plasma of humans. The concentration and activity are appropriate for calibrating automatic biochemical analyzers. The concentrations of the components are provided at two levels.

Dates and status

Registration Date: Apr 16, 2024

About this record

Access comprehensive regulatory information for Standard calibration reagent for biochemical quantitative testing 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 240000812/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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