Roche Cobas Difficult Clostridium difficile detection reagent - Taiwan Registration 3bacb9cc0fe87e8b24077a4aa4ac6cc8
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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Device Details
Product Details
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).
C Immunology and Microbiology; A Clinical chemistry and clinical toxicology
C.3130 Clostridium Dystoxin Gene Enhancement Agent;; A.1660 Quality control materials (analytical and non-analytical)
import
Dates and Status
Oct 01, 2018
Oct 01, 2028