Roche immunoassay free thyroxine fourth generation assay - Taiwan Registration 9d5c6d90f7cbe37e8c9803f64bda23c8
Access comprehensive regulatory information for Roche immunoassay free thyroxine fourth generation assay in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9d5c6d90f7cbe37e8c9803f64bda23c8 and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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Device Details
Product Details
Model 09043276190: This product uses electrochemiluminescence immunoassay (ECLIA) with cobas e 411, cobas e 601, cobas 602 analyzers to quantitatively detect free thyroxine in human serum and plasma in vitro. Model 09043284190: This product uses electrochemiluminescence immunoassay (ECLIA) with cobas 402 and cobas e 801 immunoassay analyzer to quantitatively detect free thyroxine in human serum and plasma in vitro. Model 09043292190: This product is used on the Cobas E Immunoassay Analyzer to correct the Elecsys FT4 IV Quantitative Reagent.
A Clinical chemistry and clinical toxicology
A.1695 ๆธธ้ข็ฒ็่ บ็ด ่ฉฆ้ฉ็ณป็ตฑ;; A.1150 ๆ กๆญฃๅ
Input;; QMS/QSD
Dates and Status
Jan 31, 2023
Jan 31, 2028