Taiwan FDA registration 36135dc8ce9e6bce4d62e4db2260114c
BD Gram-negative drug susceptibility reagents
TW: BD 革蘭氏陰性菌藥物敏感性試劑組
Taiwan·Risk Class 2·BECTON DICKINSON AND COMPANY·Registered Jun 12, 2023 – Jun 12, 2028ActiveRegistration details
- Analysis ID
- 36135dc8ce9e6bce4d62e4db2260114c
- Customs Code
- DHA05603618908
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 (the types listed in Table 1) are used for rapid identification and drug tolerance testing of most Gram-negative aerobic and facultative anaerobic bacteria of human origin, and must be used with Phoenix Automatic Microbial System instrumentation.
- 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
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Jun 12, 2023
- Expiry Date
- Jun 12, 2028
About this record
Access comprehensive regulatory information for BD Gram-negative drug susceptibility reagents in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 36135dc8ce9e6bce4d62e4db2260114c 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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