Vietnam MOH registration 240000753/PCBB-HCM

Material for the Control of Quantitative Immunoassays

VN: Vật liệu kiểm soát các xét nghiệm định lượng Miễn Dịch
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Vietnam flagVietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Randox Laboratories Ltd·Registered Apr 11, 2024
Registration details
Analysis ID
240000753/PCBB-HCM
Submission ID
000.00.19.H29-240402-0011
Product Type
Theo theo phụ lục
Product Code
Theo phụ lục
Company information
Manufacturer Country
Theo theo phụ lục
Product Owner
Randox Laboratories Ltd
Technical details
Intended Use
This product is designed for in vitro diagnostic use, as a quality control material to monitor the accuracy and reproducibility of immunoassays
Dates and status
Registration Date
Apr 11, 2024
About this record

Access comprehensive regulatory information for Material for the Control of Quantitative Immunoassays 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 240000753/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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