IVD Department Quantitative Cystatin C Testing
Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·APTEC DIAGNOSTICS NV·Registered Oct 24, 2024- Analysis ID
- 240002868/PCBB-HN
- Submission ID
- 000.00.19.H26-241015-0031
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- APTEC DIAGNOSTICS NV
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- APTEC DIAGNOSTICS NV
- Authorized Representative
- CÔNG TY TNHH KHOA HỌC KỸ THUẬT HƯỚNG DƯƠNG
- Intended Use
- Cystatin C KIT: Quantitative determination of Cystatin C in human serum by turbidimetric immunoassay. Cystatin C Standard: Reference curve preparation for the quantitative determination of Cystatin C in human serum by chemiluminescence immunoassay. Cystatin C Control High: Control accuracy of the turbidimetric immunoassay for quantitative determination of Cystatin C in human serum. Cystatin C Control Low: Control accuracy of the turbidimetric immunoassay for quantitative determination of Cystatin C in human serum.
- Registration Date
- Oct 24, 2024
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Access comprehensive regulatory information for IVD Department Quantitative Cystatin C Testing in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002868/PCBB-HN and manufactured by APTEC DIAGNOSTICS NV. The authorized representative in Vietnam is CÔNG TY TNHH KHOA HỌC KỸ THUẬT HƯỚNG DƯƠNG.
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