Taiwan FDA registration 97419e3f938e5b4c11d77cbdc1e177e5
Ojie anti-nucleolar antibody test group
TW: 歐捷抗核仁抗體測試組
Taiwan·Risk Class 2·ORGENTEC DIAGNOSTIKA GMBH·Registered Jul 31, 2012 – Jul 31, 2027ActiveRegistration details
- Analysis ID
- 97419e3f938e5b4c11d77cbdc1e177e5
- Customs Code
- DHA00602382509
Company information
- Manufacturer
- ORGENTEC DIAGNOSTIKA GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- IN FUNG CO., LTD.
Product details
- Intended Use
- Semi-quantitative detection of nuclear antigens of autologous antibodies IgG:dsDNA, nucleosomes, SS-A, SS-B, SM, RNP/SM, Scl-70, Jo-1, and Centromere B.
- 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 Ojie anti-nucleolar 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 97419e3f938e5b4c11d77cbdc1e177e5 and manufactured by ORGENTEC DIAGNOSTIKA GMBH. The authorized representative in Taiwan is IN FUNG CO., LTD..
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