Taiwan FDA registration 40a3a60ba236d90d00708818c06477a7

BD MAX Clostridium difficile detection reagent

TW: BD MAX困難梭狀芽孢桿菌檢測試劑
Taiwan flagTaiwan·Risk Class 2·Benex Limited;; GeneOhm Sciences Canada, ULC.·Registered May 12, 2018 – May 12, 2028Active
Registration details
Analysis ID
40a3a60ba236d90d00708818c06477a7
Customs Code
DHA05603110901
Company information
Manufacturer Country
Canada;;Ireland
Product details
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 fluid stool 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.
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
import
Dates and status
Registration Date
May 12, 2018
Expiry Date
May 12, 2028
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About this record

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 40a3a60ba236d90d00708818c06477a7 and manufactured by Benex Limited;; 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 BECTON DICKINSON AND COMPANY;; GeneOhm Sciences Canada, ULC., GENEOHM SCIENCES CANADA, INC., 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.

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