Taiwan FDA registration 181280742cabbf7953045e067a9a4246

Roche immunoassay for highly sensitive myocardial rotation protein T

TW: 羅氏免疫分析高敏感心肌旋轉蛋白T檢驗試劑
Taiwan flagTaiwan·Risk Class 2·ROCHE DIAGNOSTICS GMBH·Registered Dec 29, 2022 – Dec 29, 2027Active
Registration details
Analysis ID
181280742cabbf7953045e067a9a4246
Customs Code
DHA05603589401
Company information
Manufacturer Country
Germany
Authorized Representative
ROCHE DIAGNOSTICS LTD.
Product details
Intended Use
This product uses electrochemiluminescence immunoassay (ECLIA) to quantitatively detect human serum and plasma central myorotation protein T (Troponin T) content on cobas e immunoassay in vitro.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1215 Creatine phosphokinase/creatine kinase or isoenzyme testing system; A.1150 calibration
Import Information
QMS/QSD;; 輸入
Dates and status
Registration Date
Dec 29, 2022
Expiry Date
Dec 29, 2027
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About this record

Access comprehensive regulatory information for Roche immunoassay for highly sensitive myocardial rotation protein T in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 181280742cabbf7953045e067a9a4246 and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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