Taiwan FDA registration ddbfd870f40b025a3fd62d855a457ef5

BD Gram-Negative Bacteria Drug Susceptibility Reagent Panel-Penicillenes

TW: BD 革蘭氏陰性菌藥物敏感性試劑組-青黴烯類

Taiwan·Risk Class 2·BECTON DICKINSON AND COMPANY·Registered Nov 07, 2024 – Nov 07, 2029Active

Registration details

Analysis ID: ddbfd870f40b025a3fd62d855a457ef5
Customs Code: DHA05603751207

Company information

Manufacturer: BECTON DICKINSON AND COMPANY
Manufacturer Country: United States
Authorized Representative: BECTON DICKINSON HOLDINGS PTE. LTD. TAIWAN BRANCH (SINGAPORE)

Product details

Intended Use: This product contains selective antimicrobials (listed in Table 1 of the instructions) for drug tolerance testing against most gram-negative aerobic and facultative anaerobes, and must be used with the Phoenix Automated Microbiological System instrument.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.1645 Automatic Antibiotic Sensitivity Test System for Short Incubation Period
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Nov 07, 2024
Expiry Date: Nov 07, 2029

About this record

Access comprehensive regulatory information for BD Gram-Negative Bacteria Drug Susceptibility Reagent Panel-Penicillenes in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ddbfd870f40b025a3fd62d855a457ef5 and manufactured by BECTON DICKINSON AND COMPANY. The authorized representative in Taiwan is BECTON DICKINSON HOLDINGS PTE. LTD. TAIWAN BRANCH (SINGAPORE).

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