Taiwan FDA registration e1366be7c28af27f6028d599661f5d7b
Vitros Immunodiagnostic Products Total PSA II
TW: 維特司總前列腺特異性抗原II免疫檢驗試劑組
Taiwan·Risk Class 2·MD·ORTHO-CLINICAL DIAGNOSTICS·Registered Jan 27, 2014 – Jan 27, 2024ExpiredRegistration details
- Analysis ID
- e1366be7c28af27f6028d599661f5d7b
- License Form
- Ministry of Health Medical Device Import No. 025865
- Customs Code
- DHA05602586501
Company information
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Manufacturer Country
- United Kingdom
- Authorized Representative
- DKSH TAIWAN LTD.
Product details
- Intended Use
- This product is used to quantitatively detect the content of total prostate-specific antigen (free and conjugated, tPSA) in human serum and plasma (using heparin or EDTA as anticoagulants), and needs to be used with Vitex ECi/ECiQ Immunodiagnostic Analyzer, Vitex 3600 Immunodiagnostic Analyzer and Vitex 5600 Biochemical Immunoassay Analyzer.
- 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, 2024
About this record
Access comprehensive regulatory information for Vitros Immunodiagnostic Products Total PSA II in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e1366be7c28af27f6028d599661f5d7b 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.
Free DatabasePowered by Pure Global AI89,000+ Devices