Taiwan FDA registration c044f2c2eb323dbb931e2ed11c899dc1
IRIA RNA POL III ANTIBODY DETECTION REAGENT
TW: 宜立亞RNA Pol Ⅲ抗體檢測試劑
Taiwan·Risk Class 2·PHADIA AB;; PHADIA GMBH·Registered Nov 24, 2016 – Nov 24, 2026ActiveRegistration details
- Analysis ID
- c044f2c2eb323dbb931e2ed11c899dc1
- Customs Code
- DHA05602896902
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 IgG antibodies of RNA polymerase III (RNA Pol III.) in human serum and plasma to assist in the clinical diagnosis of systemic sclerosis (diffuse type). This product is tested using the ILIA IgG method on the Fadia 250 instrument.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.5100 抗核抗體免疫試驗系統
- Import Information
- import
Dates and status
- Registration Date
- Nov 24, 2016
- Expiry Date
- Nov 24, 2026
About this record
Access comprehensive regulatory information for IRIA RNA POL III ANTIBODY 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 c044f2c2eb323dbb931e2ed11c899dc1 and manufactured by PHADIA AB;; PHADIA GMBH. The authorized representative in Taiwan is PHADIA TAIWAN INC..
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