Taiwan FDA registration efb414c6bc17964282e13977c7bf4338
Vitex biochemical products cocaine metabolite reagent
TW: 維特司生化產品可卡因代謝物試劑
Taiwan·Risk Class 2·ORTHO-CLINICAL DIAGNOSTICS, INC.;; ORTHO-CLINICAL DIAGNOSTICS, INC·Registered May 14, 2009 – May 14, 2024ExpiredRegistration details
- Analysis ID
- efb414c6bc17964282e13977c7bf4338
- Customs Code
- DHA00602001001
Company information
- Manufacturer Country
- United States
- Authorized Representative
- DKSH TAIWAN LTD.
Product details
- Intended Use
- The Vitex Cocaine Metabolite Kit is used on the VITROS 5,1 FS Chemical Analyzer for semi-quantitative or qualitative determination of benzoyl ecgonine (cocaine metabolite) in human urine using cut-off values of 150 ng/mL or 300 ng/mL.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.3250 Cocaine and its metabolites test system
- Import Information
- import
Dates and status
- Registration Date
- May 14, 2009
- Expiry Date
- May 14, 2024
About this record
Access comprehensive regulatory information for Vitex biochemical products cocaine metabolite reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number efb414c6bc17964282e13977c7bf4338 and manufactured by ORTHO-CLINICAL DIAGNOSTICS, INC.;; ORTHO-CLINICAL DIAGNOSTICS, INC. The authorized representative in Taiwan is DKSH TAIWAN LTD..
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