BD MAX Clostridium difficile detection reagent
Taiwan·Risk Class 2·BECTON DICKINSON AND COMPANY;; GeneOhm Sciences Canada, ULC.·Registered Jul 15, 2021 – Jul 15, 2026Expired- Analysis ID
- 35dbd32b56bcbcfc16bfa3d6d19880ca
- Customs Code
- DHA05603467701
- Manufacturer Country
- Canada;;United States
- Authorized Representative
- BECTON DICKINSON HOLDINGS PTE. LTD. TAIWAN BRANCH (SINGAPORE)
- Intended Use
- Used with the BD MAX System, this product is an automated in vitro diagnostic reagent for the direct qualitative detection of Clostridium difficile toxin B gene (tcdB) in human fluids or soft stool samples from patients suspected of Clostridium difficile infection (CDI). This is a test performed directly on the sample using real-time polymerase chain reaction (PCR) to amplify the DNA DNA of the Clostridium difficile toxin B gene and detect amplified DNA with fluorescent target-specific hybridization probes. This product is intended to assist in the diagnosis of Clostridium difficile infection (CDI).
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3130 困難梭狀桿菌毒素基因擴增試劑
- Import Information
- Input;; QMS/QSD
- Registration Date
- Jul 15, 2021
- Expiry Date
- Jul 15, 2026
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Access comprehensive regulatory information for BD MAX 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 35dbd32b56bcbcfc16bfa3d6d19880ca and manufactured by BECTON DICKINSON AND COMPANY;; GeneOhm Sciences Canada, ULC.. The authorized representative in Taiwan is BECTON DICKINSON HOLDINGS PTE. LTD. TAIWAN BRANCH (SINGAPORE).
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including GENEOHM SCIENCES CANADA, INC., Benex Limited;; GeneOhm Sciences Canada, ULC., and 2 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.