Taiwan FDA registration 3bacb9cc0fe87e8b24077a4aa4ac6cc8

Roche Cobas Difficult Clostridium difficile detection reagent

TW: 羅氏可霸斯困難梭狀芽孢桿菌檢測試劑

Taiwan·Risk Class 2·ROCHE MOLECULAR SYSTEMS, INC.·Registered Oct 01, 2018 – Oct 01, 2028Active

Registration details

Analysis ID: 3bacb9cc0fe87e8b24077a4aa4ac6cc8
Customs Code: DHA05603148806

Company information

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

Product details

Intended Use: This product is used with the in vitro diagnostic reagent of the cobas 4800 automated system for the qualitative detection of unformed (liquid or soft) stool samples in patients suspected of Clostridium difficile infection (CDI), and the direct detection of toxin B (tcdB) gene of C. difficile using real-time polymerase chain reaction (PCR).
Product Type (Level 1): C Immunology and Microbiology; A Clinical chemistry and clinical toxicology
Product Type (Level 2): C.3130 Clostridium Dystoxin Gene Enhancement Agent;; A.1660 Quality control materials (analytical and non-analytical)
Import Information: import

Dates and status

Registration Date: Oct 01, 2018
Expiry Date: Oct 01, 2028

About this record

Access comprehensive regulatory information for Roche Cobas Difficult Clostridium difficile 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 3bacb9cc0fe87e8b24077a4aa4ac6cc8 and manufactured by ROCHE MOLECULAR SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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