Vietnam MOH registration 240000023/PCBB-BYT

Quantitative Ferritin and Vitamin B12 Testing Control Material

VN: Vật liệu kiểm soát xét nghiệm định lượng Ferritin và Vitamin B12

Vietnam·Risk Class TTBYT Loại B·VITROS Immunodiagnostic Products Anemia Controls·Ortho-Clinical Diagnostics·Registered Feb 23, 2024

Registration details

Analysis ID: 240000023/PCBB-BYT
Submission ID: 000.00.04.G18-240223-0003
Product Type: VITROS Immunodiagnostic Products Anemia Controls
Product Code: 1619360

Company information

Manufacturer: Ortho-Clinical Diagnostics
Manufacturer Country: Pencoed Bridgend CF35 5PZ
Product Owner: Ortho-Clinical Diagnostics
Authorized Representative: CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM

Technical details

Intended Use: It is used in in vitro diagnostic monitoring of the performance of the VITROS ECi / ECiQ, VITROS 3600 and the integrated VITROS 5600/XT 7600 systems when quantifying the analytes as listed in the corresponding User Manuals.

Dates and status

Registration Date: Feb 23, 2024

About this record

Access comprehensive regulatory information for Quantitative Ferritin and Vitamin B12 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 240000023/PCBB-BYT and manufactured by Ortho-Clinical Diagnostics. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.

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