Taiwan FDA registration 42fffe235099e55d6a6fefd7c945bd2e

BD Gram-negative Drug Susceptibility Reagent Panel-Quinolones

TW: BD 革蘭氏陰性菌藥物敏感性試劑組-喹諾酮類

Taiwan·Risk Class 2·Becton, Dickinson and Company·Registered Nov 26, 2024 – Nov 26, 2029Active

Registration details

Analysis ID: 42fffe235099e55d6a6fefd7c945bd2e
Customs Code: DHA05603751806

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 antimicrobial drugs (listed in Table 1 of the instructions) for drug tolerance testing against most gram-negative aerobic bacteria and facultative anaerobes, and must be used with Phoenix automatic microbial system instruments.
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 26, 2024
Expiry Date: Nov 26, 2029

About this record

Access comprehensive regulatory information for BD Gram-negative Drug Susceptibility Reagent Panel-Quinolones in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 42fffe235099e55d6a6fefd7c945bd2e 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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