Taiwan FDA registration 6fe035de451c3fd1aabb9918063e660a

Iliavein 2 detection reagent

TW: 宜立亞鈣衛蛋白2檢測試劑

Taiwan·Risk Class 2·PHADIA AB;; PHADIA GMBH·Registered Oct 30, 2017 – Oct 30, 2027Active

Registration details

Analysis ID: 6fe035de451c3fd1aabb9918063e660a
Customs Code: DHA05603045104

Company information

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

Product details

Intended Use: This product is used for the in vitro quantitative determination of calprotectin in human feces to assist in the clinical diagnosis of inflammatory bowel disease (IBD). This product was tested using the EIFIA Calprotectin 2 method in the Fadia 200 and Fadia 250 instruments.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.5180 Fecal calprotectin immunoassay system
Import Information: import

Dates and status

Registration Date: Oct 30, 2017
Expiry Date: Oct 30, 2027

About this record

Access comprehensive regulatory information for Iliavein 2 detection reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 6fe035de451c3fd1aabb9918063e660a and manufactured by PHADIA AB;; PHADIA GMBH. The authorized representative in Taiwan is PHADIA TAIWAN INC..

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