Taiwan FDA registration 1179c132c65b06a17bdc039393c2f060

Vitex C peptide immunoassay correction solution

TW: 維特司C胜肽免疫檢測校正液

Taiwan·Risk Class 2·ORTHO-CLINICAL DIAGNOSTICS·Registered May 14, 2021 – May 14, 2026Expired

Registration details

Analysis ID: 1179c132c65b06a17bdc039393c2f060
Customs Code: DHA05603465501

Company information

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

Product details

Intended Use: The Vitex ECiQ Immunodiagnostic Analyzer, Vitex 3600 Immunodiagnostic Analyzer, Vitex 5600 Biochemical Immunoassay Analyzer and Vitex XT7600 Biochemical Immunoassay Analyzer were corrected for the quantitative determination of C peptide in human serum and plasma (EDTA and heparin lithium).
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1150 Calibrated Products
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: May 14, 2021
Expiry Date: May 14, 2026

About this record

Access comprehensive regulatory information for Vitex C peptide immunoassay correction solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 1179c132c65b06a17bdc039393c2f060 and manufactured by ORTHO-CLINICAL DIAGNOSTICS. The authorized representative in Taiwan is DKSH TAIWAN LTD..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.