CYFRA 21-1 Quantitative Testing Drug - Vietnam Registration 2402509ĐKLH/BYT-HTTB
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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Device Details
Registration Details
2402509ĐKLH/BYT-HTTB
000.00.04.G18-230522-0007
Elecsys CYFRA 21-1
11820966214
Technical Details
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.
Dates and Status
Aug 30, 2024