Taiwan FDA registration ab61e61c60c7b70d17bedf8cb263151c

"Ilia" IgG calibration antibody (unsterilized)

TW: “宜立亞”IgG標定抗體 (未滅菌)

Taiwan·Risk Class 1·PHADIA AB;; PHADIA GMBH·Registered Sep 03, 2014 – Sep 03, 2029Active

Registration details

Analysis ID: ab61e61c60c7b70d17bedf8cb263151c
Customs Code: DHA09401447405

Company information

Manufacturer: PHADIA AB;; PHADIA GMBH
Manufacturer Country: Sweden;;Germany
Authorized Representative: PHADIA TAIWAN INC.

Product details

Intended Use: Limited to the first level identification range of the Measures for the Classification and Grading of Medical Devices "Analysis of Specific Reagents (B.4020)".
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.4020 Analysis of specific tests
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Sep 03, 2014
Expiry Date: Sep 03, 2029

About this record

Access comprehensive regulatory information for "Ilia" IgG calibration antibody (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number ab61e61c60c7b70d17bedf8cb263151c and manufactured by PHADIA AB;; PHADIA GMBH. The authorized representative in Taiwan is PHADIA TAIWAN INC..

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