Taiwan FDA registration 6b20d3d4a42dae81b8486ac6b9d118bd
Apex benzodiazo salt assay set
TW: 亞培苯重氮基鹽類檢驗試劑組
Taiwan·Risk Class 2·MICROGENICS CORPORATION·Registered Jan 28, 2021 – Jan 28, 2026ExpiredRegistration details
- Analysis ID
- 6b20d3d4a42dae81b8486ac6b9d118bd
- Customs Code
- DHA05603435604
Company information
- Manufacturer
- MICROGENICS CORPORATION
- Manufacturer Country
- United States
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- This product is a homogeneous enzyme immunoassay for the qualitative and/or semi-quantitative detection of benzodiazepines and their metabolites in human urine at a threshold concentration of 200 ng/mL (0.700 μmol/L) on the Alinity c analyzer.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.3200 Clinical Toxicology Corrector;; A.3170 Benzodiazo salt test system
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Jan 28, 2021
- Expiry Date
- Jan 28, 2026
About this record
Access comprehensive regulatory information for Apex benzodiazo salt assay set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 6b20d3d4a42dae81b8486ac6b9d118bd and manufactured by MICROGENICS CORPORATION. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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