Roche Cobas automatic TV/MG detection reagent - Taiwan Registration fef5874402ed64f37cd981714a6f82e0
Access comprehensive regulatory information for Roche Cobas automatic TV/MG detection reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number fef5874402ed64f37cd981714a6f82e0 and manufactured by ROCHE MOLECULAR SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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Device Details
Product Details
本產品是應用於羅氏可霸斯全自動即時PCR分析儀(cobas 6800/8800 Systems)的一種全自動定性的體外診斷試劑,利用即時聚合酶鏈反應(Polymerase Chain Reaction, PCR)直接檢測陰道滴蟲(Trichomonas vaginalis, TV)和/或生殖道黴漿菌(Mycoplasma genitalium, MG)DNA,檢體為男性和女性尿液、臨床醫師指示自行採集的陰道拭子檢體、臨床醫師採集的陰道拭子檢體、子宮內頸拭子檢體、臨床醫師指示自行採集的尿道口拭子檢體、臨床醫師採集的尿道口拭子檢體. 效能變更:本產品(09040633190)是應用於羅氏可霸斯全自動即時PCR分析儀(cobas 5800/6800/8800 Systems)的一種全自動定性的體外診斷試劑,利用即時聚合酶鏈反應(Polymerase Chain Reaction, PCR)直接檢測陰道滴蟲(Trichomonas vaginalis,TV)和/或生殖道黴漿菌(Mycoplasma genitalium, MG)DNA,檢體為男性和女性尿液、臨床醫師指示自行採集的陰道拭子檢體、臨床醫師採集的陰道拭子檢體、子宮內頸拭子檢體、臨床醫師指示自行採集的尿道口拭子檢體、臨床醫師採集的尿道口拭子檢體.
C Immunology and microbiology
C.3860 陰道滴蟲核酸檢驗試劑;; C.3375 黴漿菌屬血清試劑
Input;; QMS/QSD
Dates and Status
Dec 15, 2020
Dec 15, 2025