Taiwan FDA registration f363ce2beaf1d9a74a7475123613a75e

BD MAX Intestinal Parasite Test Kit

TW: BD MAX腸道寄生蟲檢測套組

Taiwan·Risk Class 2·Benex Limited;; GeneOhm Sciences Canada, ULC.·Registered Aug 02, 2018 – Aug 02, 2028Active

Registration details

Analysis ID: f363ce2beaf1d9a74a7475123613a75e
Customs Code: DHA05603134701

Company information

Manufacturer: Benex Limited;; GeneOhm Sciences Canada, ULC.
Manufacturer Country: Canada;;Ireland
Authorized Representative: BECTON DICKINSON HOLDINGS PTE. LTD. TAIWAN BRANCH (SINGAPORE)

Product details

Intended Use: This product can be used with the BD MAX system to automatically detect and distinguish nucleic acids of intestinal parasitic pathogens (Giardia lamblia), Cryptosporidium (only human Cryptosporidium (C. hominis and C. parvum) and Entamoeba histolytica).
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3990 胃腸道微生物多標的核酸檢驗試劑
Import Information: import

Dates and status

Registration Date: Aug 02, 2018
Expiry Date: Aug 02, 2028

About this record

Access comprehensive regulatory information for BD MAX Intestinal Parasite Test Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f363ce2beaf1d9a74a7475123613a75e and manufactured by Benex Limited;; GeneOhm Sciences Canada, ULC.. The authorized representative in Taiwan is BECTON DICKINSON HOLDINGS PTE. LTD. TAIWAN BRANCH (SINGAPORE).

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