CYFRA 21-1 Quantitative Testing Drug
Vietnam·Risk Class TTBYT Loại C·Elecsys CYFRA 21-1·Roche Diagnostics (Suzhou) Ltd.·Registered Aug 30, 2024- Analysis ID
- 2402509ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-230522-0007
- Product Type
- Elecsys CYFRA 21-1
- Product Code
- 11820966214
- Manufacturer
- Roche Diagnostics (Suzhou) Ltd.
- Manufacturer Country
- CHINA
- Authorized Representative
- CÔNG TY TNHH ROCHE VIỆT NAM
- Intended Use
- In vitro immunoassay for quantification of cytokeratin 19 fragments in human serum and plasma. The ECLIA (electrochemiluminescence immunoassay “ECLIA”) is used in the cobas e immunoassay system.
- Registration Date
- Aug 30, 2024
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Access comprehensive regulatory information for CYFRA 21-1 Quantitative Testing Drug in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2402509ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics (Suzhou) Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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