Beckman Coulter Gnosis Ekantamine Enzyme Immunoassay Set - Taiwan Registration 8ac47fdd4b77ee7ff333d4f85c3c329e
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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Device Details
Product Details
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).
A Clinical chemistry and clinical toxicology
A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products;; A.0001 ่ฏ็ฐๅฉๅฎ่ฉฆ้ฉ็ณป็ตฑ
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Aug 19, 2022
Aug 19, 2027

