Taiwan FDA registration 8550608d68b9e38158f94a1e08f5b1da
Ojet's antinuclear antibody test group
TW: 歐捷抗核抗體測試組
Taiwan·Risk Class 2·ORGENTEC DIAGNOSTIKA GMBH·Registered Jul 31, 2012 – Jul 31, 2027ActiveRegistration details
- Analysis ID
- 8550608d68b9e38158f94a1e08f5b1da
- Customs Code
- DHA00602382700
Company information
- Manufacturer
- ORGENTEC DIAGNOSTIKA GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- IN FUNG CO., LTD.
Product details
- Intended Use
- This product is a membrane for semi-quantitative detection of autologous antibodies IgG against extractable nuclear antigens (ENAs), including: SS-A 52, SS-A 60, SS-B, RNP/SM, SM, Centromere B (central segment B), Jo-1, Scl-70 and ribosomal P proteins. This test can only be used in vitro to help diagnose rheumatoid autoimmune diseases.
- 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
- Jul 31, 2012
- Expiry Date
- Jul 31, 2027
About this record
Access comprehensive regulatory information for Ojet's antinuclear antibody test group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8550608d68b9e38158f94a1e08f5b1da and manufactured by ORGENTEC DIAGNOSTIKA GMBH. The authorized representative in Taiwan is IN FUNG CO., LTD..
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