BD MAX Clostridium difficile detection reagent - Taiwan Registration 35dbd32b56bcbcfc16bfa3d6d19880ca
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.
Device Details
Registration Details
35dbd32b56bcbcfc16bfa3d6d19880ca
DHA05603467701
Product Details
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).
C Immunology and microbiology
C.3130 ๅฐ้ฃๆขญ็ๆกฟ่ๆฏ็ด ๅบๅ ๆดๅข่ฉฆๅ
Input;; QMS/QSD
Dates and Status
Jul 15, 2021
Jul 15, 2026
BD MAX Clostridium difficile detection reagent
Benex Limited;; GeneOhm Sciences Canada, ULC.
40a3a60ba236d90d00708818c06477a7
2
BD MAX Clostridium difficile detection reagent (unsterilized)
GENEOHM SCIENCES CANADA, INC.
3c42e43d9580ec6b88a2855af21add3d
1