IVD Department Quantitative Cystatin C Testing
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Registered Mar 28, 2024- Analysis ID
- 240000660/PCBB-HN
- Submission ID
- 000.00.19.H26-240306-0020
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Authorized Representative
- CÔNG TY TNHH VẠN NIÊN
- Intended Use
- - Cystatin C FS: A diagnostic test to determine the concentration of cystatin C in human serum or heparinized blood plasma in vitro. - Cystatin C FS: A diagnostic test to determine the concentration of cystatin C in human serum or heparinized blood plasma in an automated fluorescence system. - TruCal Cystatin C: A calibration kit for use in in vitro diagnostic tests to determine the concentration of cystatin C by fluorescence. - TruLab Cystatin C Level 1: A quality control material for in vitro diagnostic tests to monitor the performance of the test for determining the concentration of cystatin C. - TruLab Cystatin C Level 2: A quality control material for in vitro diagnostic tests to monitor the performance of the test for determining the concentration of cystatin C.
- Registration Date
- Mar 28, 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 TTBYT Loại B medical device is registered under number 240000660/PCBB-HN. The authorized representative in Vietnam is CÔNG TY TNHH VẠN NIÊN.
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