Taiwan FDA registration ecd51e5abd3b59de2e071170d406cc4c

Roche Coba Slater Difficult Clostridium difficile rapid test reagent

TW: 羅氏可霸斯萊特困難梭狀桿菌快速檢驗試劑

Taiwan·Risk Class 2·Roche Molecular Systems, Inc.·Registered May 10, 2018 – May 10, 2028Active

Registration details

Analysis ID: ecd51e5abd3b59de2e071170d406cc4c
Customs Code: DHA05603110707

Company information

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

Product details

Intended Use: This product is an automated qualitative in vitro diagnostic test for the cobas Liat system, using real-time polymerase chain reaction (PCR) to detect toxin B (tcd B) genes in Clostridium difficile obtained from patients suspected of Clostridium difficile infection (CDI).
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: May 10, 2018
Expiry Date: May 10, 2028

About this record

Access comprehensive regulatory information for Roche Coba Slater Difficult Clostridium difficile rapid test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ecd51e5abd3b59de2e071170d406cc4c and manufactured by Roche Molecular Systems, Inc.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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