Taiwan FDA registration f37091da9c6aba4fb8eab51c7a877557

MB isoenzyme test group for Api creatine kinase

TW: 亞培肌酸激酶之MB同功酶檢驗試劑組
Taiwan flagTaiwan·Risk Class 2·SENTINEL CH. S.p.A.·Registered May 06, 2020 – May 06, 2025Expired
Registration details
Analysis ID
f37091da9c6aba4fb8eab51c7a877557
Customs Code
DHA05603347701
Company information
Manufacturer Country
Italy
Product details
Intended Use
This product is intended for the kinetic in vitro diagnostic detection of the MB isoenzyme (CK-MB) and BB isoenzyme (CK-BB) of creatine kinase in serum or plasma on the Alinity c System.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1215 Skin Acid Acid Acid Intense 酶 / Skin Acid Acid Intense 酶 或同功酶試驗系統;; A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products
Import Information
import
Dates and status
Registration Date
May 06, 2020
Expiry Date
May 06, 2025
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About this record

Access comprehensive regulatory information for MB isoenzyme test group for Api creatine kinase in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f37091da9c6aba4fb8eab51c7a877557 and manufactured by SENTINEL CH. S.p.A.. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.;; ABBOTT IRELAND DIAGNOSTICS DIVISION, and 1 recent registrations in the same category. 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.

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