"Vitex" immunoassay reagent HBe quality control solution - Taiwan Registration 33ec2a8e24b4a8d05fbecf43058b38e5
Access comprehensive regulatory information for "Vitex" immunoassay reagent HBe quality control solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 33ec2a8e24b4a8d05fbecf43058b38e5 and manufactured by ORTHO-CLINICAL DIAGNOSTICS. The authorized representative in Taiwan is DKSH TAIWAN LTD..
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Device Details
Product Details
This product is used on the Vitex ECi/ECiQ/3600 Immunodiagnostic Analyzer and the Vitex 5600/XT 7600 Biochemical Immunoassay Analyzer to monitor the performance of the analyzers for the determination of Anti-HBe and HBeAg.
A Clinical chemistry and clinical toxicology
A.1660 Quality control materials (analytical and non-analytical)
Input;; QMS/QSD
Dates and Status
Oct 19, 2022
Oct 19, 2027

