Taiwan FDA registration 9d5c6d90f7cbe37e8c9803f64bda23c8

Roche immunoassay free thyroxine fourth generation assay

TW: 羅氏免疫分析游離甲狀腺素第四代檢驗試劑

Taiwan·Risk Class 2·ROCHE DIAGNOSTICS GMBH·Registered Jan 31, 2023 – Jan 31, 2028Active

Registration details

Analysis ID: 9d5c6d90f7cbe37e8c9803f64bda23c8
Customs Code: DHA05603615402

Company information

Manufacturer: ROCHE DIAGNOSTICS GMBH
Manufacturer Country: Germany
Authorized Representative: ROCHE DIAGNOSTICS LTD.

Product details

Intended Use: 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.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1695 游離甲狀腺素試驗系統;; A.1150 校正品
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Jan 31, 2023
Expiry Date: Jan 31, 2028

About this record

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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