Taiwan FDA registration af6085166681e12531dc83bafcfe6c3a

Vitros Immunodiagnostic Products Free PSA

TW: 維特司游離前列腺特異性抗原免疫檢驗試劑組

Taiwan·Risk Class 2·MD·ORTHO-CLINICAL DIAGNOSTICS·Registered Jan 27, 2014 – Jan 27, 2029Active

Registration details

Analysis ID: af6085166681e12531dc83bafcfe6c3a
License Form: Ministry of Health Medical Device Import No. 025864
Customs Code: DHA05602586409

Company information

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

Product details

Intended Use: The changed efficacy is: This product is used to quantitatively determine the content of free prostate-specific antigen (fPSA) in human serum and plasma (containing heparin or EDTA) samples using the Vitex ECi/ECiQ Immunodiagnostic Analyzer, Vitex 3600 Immunodiagnostic Analyzer and Vitex 5600/XT7600 Biochemical Immunoassay Analyzer, and then combined with Vitex Total PSA II to convert the ratio of free prostate-specific antigen to total prostate-specific antigen (%fPSA).
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C6010 Tumor-associated antigen immunoassay system
Import Information: Imported from abroad

Dates and status

Registration Date: Jan 27, 2014
Expiry Date: Jan 27, 2029

About this record

Access comprehensive regulatory information for Vitros Immunodiagnostic Products Free PSA in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number af6085166681e12531dc83bafcfe6c3a and manufactured by ORTHO-CLINICAL DIAGNOSTICS. The authorized representative in Taiwan is DKSH TAIWAN LTD..

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