Taiwan FDA registration 09ba47273d389ee348a43fd6324bca4d

"Vitex" immunoassay group complete parathyroid

TW: “維特司”免疫檢驗試劑組完整副甲狀腺
Taiwan flagTaiwan·Risk Class 2·ORTHO-CLINICAL DIAGNOSTICS·Registered May 17, 2011 – May 17, 2026Expired
Registration details
Analysis ID
09ba47273d389ee348a43fd6324bca4d
Customs Code
DHA00602201202
Company information
Manufacturer Country
United Kingdom
Authorized Representative
DKSH TAIWAN LTD.
Product details
Intended Use
In vitro diagnostics is used to quantitatively test the concentration of intact parathyroid (iPTH) in human serum or plasma (EDTA or heparin). It is required for use with the VITROS Eci/ECiQ Immunodiagnostic Systems (VITROS 5600 Integrated System).
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products;; A.1545 Paracyathroglands Geki Hypogenealogy
Import Information
import
Dates and status
Registration Date
May 17, 2011
Expiry Date
May 17, 2026
About this record

Access comprehensive regulatory information for "Vitex" immunoassay group complete parathyroid in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 09ba47273d389ee348a43fd6324bca4d and manufactured by ORTHO-CLINICAL DIAGNOSTICS. The authorized representative in Taiwan is DKSH TAIWAN LTD..

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