Abbott designer creatine kinase MB isoenzyme test kit
- Analysis ID
- 9347f1d49e09d077ed735b732e8ddf67
- Customs Code
- DHA00601513004
- Manufacturer Country
- Ireland;;United States
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
- Intended Use
- This product is used for the quantitative detection of the MB isoenzyme of creatine kinase in human serum and plasma by chemical cold light microparticle immunoassay (CMIA) on the ARCHITECT i system equipped with the STAT program.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1215 Creatine phosphokinase/creatine kinase or isoenzyme testing system
- Import Information
- import
- Registration Date
- May 02, 2024
- Expiry Date
- Nov 30, 2025
Access comprehensive regulatory information for Abbott designer creatine kinase MB isoenzyme test kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9347f1d49e09d077ed735b732e8ddf67 and manufactured by FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.;; ABBOTT IRELAND DIAGNOSTICS DIVISION. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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.