Taiwan FDA registration 18c9a2f98a0427b096958e09770083aa
Vitex Biochemical Total Bilirubin-Alkaline Phosphatase Test Tablets
TW: 維特司生化產品總膽紅素-鹼性磷酸酶試藥片
Taiwan·Risk Class 2·ORTHO-CLINICAL DIAGNOSTICS, INC.·Registered Feb 08, 2022 – Feb 08, 2027ActiveRegistration details
- Analysis ID
- 18c9a2f98a0427b096958e09770083aa
- Customs Code
- DHA05603521708
Company information
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- DKSH TAIWAN LTD.
Product details
- Intended Use
- With the VITROS XT 3400 and VITROS XT 7600 Biochemical Immunoassay Analyzer, TBIL and ALKP detection reagents were used to quantitatively determine the total bilirubin (TBIL) concentration and alkaline phosphatase (ALKP) activity in serum and plasma, respectively.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1050 Alkaline phosphatase or isoenzyme testing system;; A.1110 Bilirubin (total or direct) test system
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Feb 08, 2022
- Expiry Date
- Feb 08, 2027
About this record
Access comprehensive regulatory information for Vitex Biochemical Total Bilirubin-Alkaline Phosphatase Test Tablets in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 18c9a2f98a0427b096958e09770083aa and manufactured by ORTHO-CLINICAL DIAGNOSTICS, INC.. 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