Taiwan FDA registration 07ac2736ab4511b6a9dc244195581224
ILIA PM-SCL ANTIBODY DETECTION REAGENT
TW: 宜立亞PM-Scl抗體檢測試劑
Taiwan·Risk Class 2·PHADIA AB;; PHADIA GMBH·Registered May 06, 2013 – May 06, 2028ActiveRegistration details
- Analysis ID
- 07ac2736ab4511b6a9dc244195581224
- Customs Code
- DHA00602472306
Company information
- Manufacturer
- PHADIA AB;; PHADIA GMBH
- Manufacturer Country
- Sweden;;Germany
- Authorized Representative
- PHADIA TAIWAN INC.
Product details
- Intended Use
- The ILIA PM-Scl antibody assay is used for the in vitro quantitative determination of IgG antibodies to PM-Scl in human serum and plasma. EliA PM-Scl was measured using the EliA IgG method on the Phadia 100 and Phadia 250 instruments. Performance changes (new applicable models) are: as detailed in the approved version of the Chinese manual.
- 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
- May 06, 2013
- Expiry Date
- May 06, 2028
About this record
Access comprehensive regulatory information for ILIA PM-SCL 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 07ac2736ab4511b6a9dc244195581224 and manufactured by PHADIA AB;; PHADIA GMBH. The authorized representative in Taiwan is PHADIA TAIWAN INC..
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