Taiwan FDA registration cc4e18eed7ba9f64b713a26f37e65da1

IRIA IGM calibration antibody (unsterilized)

TW: 宜立亞 IgM標定抗體 (未滅菌)

Taiwan·Risk Class 1·PHADIA AB;; PHADIA GMBH·Registered Mar 16, 2015 – Mar 16, 2030Active

Registration details

Analysis ID: cc4e18eed7ba9f64b713a26f37e65da1
Customs Code: DHA09401500004

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: Mar 16, 2015
Expiry Date: Mar 16, 2030

About this record

Access comprehensive regulatory information for IRIA IGM 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 cc4e18eed7ba9f64b713a26f37e65da1 and manufactured by PHADIA AB;; PHADIA GMBH. The authorized representative in Taiwan is PHADIA TAIWAN INC..

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