Taiwan FDA registration 0850f18d7bef3d24f4bebcd9b7500c86
ILIA high-sensitivity Scl-70 antibody detection reagent
TW: 宜立亞高感度Scl-70抗體檢測試劑
Taiwan·Risk Class 2·PHADIA AB;; PHADIA GMBH·Registered Feb 10, 2015 – Feb 10, 2030ActiveRegistration details
- Analysis ID
- 0850f18d7bef3d24f4bebcd9b7500c86
- Customs Code
- DHA05602707100
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 quantitative analysis of anti-Scl-70 IgG antibodies in human serum and plasma. This product was measured using the IgG method of Ilia on instruments of Fadia 100, Fadia 200 and Fadia 250.
- 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
- Feb 10, 2015
- Expiry Date
- Feb 10, 2030
About this record
Access comprehensive regulatory information for ILIA high-sensitivity Scl-70 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 0850f18d7bef3d24f4bebcd9b7500c86 and manufactured by PHADIA AB;; PHADIA GMBH. The authorized representative in Taiwan is PHADIA TAIWAN INC..
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