Taiwan FDA registration 8ac47fdd4b77ee7ff333d4f85c3c329e
Beckman Coulter Gnosis Ekantamine Enzyme Immunoassay Set
TW: 貝克曼庫爾特靈知易愷他命酵素免疫分析試劑組
Taiwan·Risk Class 2·LIN-ZHI INTERNATIONAL, INC·Registered Aug 19, 2022 – Aug 19, 2027ActiveRegistration details
- Analysis ID
- 8ac47fdd4b77ee7ff333d4f85c3c329e
- Customs Code
- DHA05603569403
Company information
- Manufacturer
- LIN-ZHI INTERNATIONAL, INC
- Manufacturer Country
- United States
- Authorized Representative
- BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- This product is used for qualitative and semi-quantitative determination of norketamine in human urine with a critical value of 50 ng/mL (when corrected for norketamine).
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products;; A.0001 苯環利定試驗系統
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Aug 19, 2022
- Expiry Date
- Aug 19, 2027
About this record
Access comprehensive regulatory information for Beckman Coulter Gnosis Ekantamine Enzyme Immunoassay Set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8ac47fdd4b77ee7ff333d4f85c3c329e and manufactured by LIN-ZHI INTERNATIONAL, INC. The authorized representative in Taiwan is BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.).
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