Taiwan FDA registration fef5874402ed64f37cd981714a6f82e0

Roche Cobas automatic TV/MG detection reagent

TW: 羅氏可霸斯全自動TV/MG檢測試劑

Taiwan·Risk Class 2·ROCHE MOLECULAR SYSTEMS, INC.·Registered Dec 15, 2020 – Dec 15, 2025Expired

Registration details

Analysis ID: fef5874402ed64f37cd981714a6f82e0
Customs Code: DHA05603417207

Company information

Manufacturer: ROCHE MOLECULAR SYSTEMS, INC.
Manufacturer Country: United States
Authorized Representative: ROCHE DIAGNOSTICS LTD.

Product details

Intended Use: 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.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3860 陰道滴蟲核酸檢驗試劑;; C.3375 黴漿菌屬血清試劑
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Dec 15, 2020
Expiry Date: Dec 15, 2025

About this record

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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