Taiwan FDA registration dab127df24df1184480a7f8e80df9fa8

IRIA IGA Calibration Reagent Group

TW: 宜立亞IgA校正試劑組

Taiwan·Risk Class 2·PHADIA AB·Registered Mar 18, 2015 – Mar 18, 2030Active

Registration details

Analysis ID: dab127df24df1184480a7f8e80df9fa8
Customs Code: DHA05602718002

Company information

Manufacturer: PHADIA AB
Manufacturer Country: Sweden
Authorized Representative: PHADIA TAIWAN INC.

Product details

Intended Use: This product is paired with Fadia 100 and Fadia 250 instruments, and the Ilia IgA Correction Solution/Ilia IgA Correction Sheet needs to use the ILIA IgA Correction Slot to establish the IgA Correction Curve to analyze the patient specimen, and the Ilia IgA Correction Curve Quality-Tube Solution/the IgA Correction Curve Piece needs to use the ILIA IgA Correction Microwell Groove to control the effectiveness of the IgA Correction Curve.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1150 Calibrated Products
Import Information: import

Dates and status

Registration Date: Mar 18, 2015
Expiry Date: Mar 18, 2030

About this record

Access comprehensive regulatory information for IRIA IGA Calibration Reagent Group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number dab127df24df1184480a7f8e80df9fa8 and manufactured by PHADIA AB. The authorized representative in Taiwan is PHADIA TAIWAN INC..

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