IVD Department Quantitative Cystatin C Testing - Vietnam Registration 240000660/PCBB-HN
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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Device Details
Registration Details
240000660/PCBB-HN
000.00.19.H26-240306-0020
Theo theo phụ lục
Theo phụ lục
Technical Details
- 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.
Dates and Status
Mar 28, 2024