Taiwan FDA registration 279aaff7060e3953af20d0865c28536f

Abbott designer pre-calcitonin test group

TW: 亞培設計師前降鈣素檢驗試劑組
Taiwan flagTaiwan·Risk Class 2·FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.;; ABBOTT GMBH·Registered Oct 26, 2017 – Oct 26, 2027Active
Registration details
Analysis ID
279aaff7060e3953af20d0865c28536f
Customs Code
DHA05603008100
Company information
Manufacturer Country
United States;;Germany
Product details
Intended Use
This product uses chemical cold light particle immunoassay (CMIA) to quantitatively test human serum and plasma for precalcitonin.
Product Type (Level 1)
A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
Product Type (Level 2)
C.3210 Endotoxin Analysis Test;; A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration
Import Information
Input;; Contract manufacturing
Dates and status
Registration Date
Oct 26, 2017
Expiry Date
Oct 26, 2027
About this record

Access comprehensive regulatory information for Abbott designer pre-calcitonin test group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 279aaff7060e3953af20d0865c28536f and manufactured by FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.;; ABBOTT GMBH. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

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