Taiwan FDA registration 4351d49bb701bf02de87c98fd7840456
Elia High Sensitivity SmDP Ab Assay
TW: 宜立亞高感度 SmDP 抗體檢測試劑
Taiwan·Risk Class 2·PHADIA AB;; PHADIA GMBH·Registered Jul 31, 2023 – Jul 31, 2028ActiveRegistration details
- Analysis ID
- 4351d49bb701bf02de87c98fd7840456
- Customs Code
- DHA05603620700
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 detection of anti-Sm IgG antibodies in human serum and plasma in vitro to assist in the clinical diagnosis of systemic lupus-erythematosus (SLE). This product was tested using the Elia IgG method on the Fadia 100, Fadia 200 and Fadia 250 instruments.
- 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
- Input;; QMS/QSD
Dates and status
- Registration Date
- Jul 31, 2023
- Expiry Date
- Jul 31, 2028
About this record
Access comprehensive regulatory information for Elia High Sensitivity SmDP Ab Assay in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4351d49bb701bf02de87c98fd7840456 and manufactured by PHADIA AB;; PHADIA GMBH. The authorized representative in Taiwan is PHADIA TAIWAN INC..
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