Taiwan FDA registration a07970fd53e199687d15a2a810463eb7

Roche Cobanes automatic chlamydomia/gonococcal nucleic acid detection reagent

TW: 羅氏可霸斯全自動披衣菌/淋菌核酸檢測試劑

Taiwan·Risk Class 2·Roche Molecular Systems, Inc.·Registered Feb 25, 2021 – Feb 25, 2026Expired

Registration details

Analysis ID: a07970fd53e199687d15a2a810463eb7
Customs Code: DHA05603436403

Company information

Manufacturer: Roche Molecular Systems, Inc.
Manufacturer Country: United States
Authorized Representative: ROCHE DIAGNOSTICS LTD.

Product details

Intended Use: 本產品為體外診斷試劑,搭配cobas 6800/8800系統,利用即時聚合酶鏈反應定性偵測檢體中砂眼披衣菌(Chlamydia trachomatis, CT)及/或淋病雙球菌(Neisseria gonorrhoeae, NG)核酸試驗. 新增效能:本產品(09040501190)為體外診斷試劑,搭配cobas 5800/6800/8800系統,利用即時聚合酶鏈反應定性檢測砂眼披衣菌(Chlamydia trachomatis, CT)以及/或是淋病雙球菌(Neisseria gonorrhoeae, NG)核酸試驗.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3390 奈瑟氏菌屬直接血清試劑;; C.3120 披衣菌血清試劑
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Feb 25, 2021
Expiry Date: Feb 25, 2026

About this record

Access comprehensive regulatory information for Roche Cobanes automatic chlamydomia/gonococcal nucleic acid 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 a07970fd53e199687d15a2a810463eb7 and manufactured by Roche Molecular Systems, Inc.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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