Taiwan FDA registration 33ec2a8e24b4a8d05fbecf43058b38e5

"Vitex" immunoassay reagent HBe quality control solution

TW: "維特司" 免疫檢驗試劑HBe品管液

Taiwan·Risk Class 2·ORTHO-CLINICAL DIAGNOSTICS·Registered Oct 19, 2022 – Oct 19, 2027Active

Registration details

Analysis ID: 33ec2a8e24b4a8d05fbecf43058b38e5
Customs Code: DHA05603586504

Company information

Manufacturer: ORTHO-CLINICAL DIAGNOSTICS
Manufacturer Country: United Kingdom
Authorized Representative: DKSH TAIWAN LTD.

Product details

Intended Use: 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.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1660 Quality control materials (analytical and non-analytical)
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Oct 19, 2022
Expiry Date: Oct 19, 2027

About this record

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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