Taiwan FDA registration 6157e92670ed3206f606f767210197a8

BD MAX 呼吸道病毒檢測套組

Taiwan·Risk Class 3·Becton, Dickinson and Company;; GeneOhm Sciences Canada, ULC.·Registered Jun 20, 2024 – Jun 20, 2029Active

Registration details

Analysis ID: 6157e92670ed3206f606f767210197a8
Customs Code: DHA05603708501

Company information

Manufacturer: Becton, Dickinson and Company;; GeneOhm Sciences Canada, ULC.
Manufacturer Country: Canada;;United States
Authorized Representative: BECTON DICKINSON HOLDINGS PTE. LTD. TAIWAN BRANCH (SINGAPORE)

Product details

Intended Use: This product is intended to be used to detect and distinguish RNA from SARS-CoV-2, influenza A, influenza B, and/or RSV in patient specimens, and is not intended for the detection of influenza C.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3980 呼吸道病毒多標的核酸檢驗試劑
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Jun 20, 2024
Expiry Date: Jun 20, 2029

About this record

Access comprehensive regulatory information for BD MAX 呼吸道病毒檢測套組 in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 6157e92670ed3206f606f767210197a8 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).

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