Taiwan FDA registration 1e0ae49e30260b53413e196a6a793df4
Ojie Anti-mutant citrulline waveform protein test group
TW: 歐捷 抗突變瓜胺酸波形蛋白測試組
Taiwan·Risk Class 2·ORGENTEC DIAGNOSTIKA GMBH·Registered Nov 20, 2012 – Nov 20, 2022CancelledRegistration details
- Analysis ID
- 1e0ae49e30260b53413e196a6a793df4
- Customs Code
- DHA00602411904
Company information
- Manufacturer
- ORGENTEC DIAGNOSTIKA GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- IN FUNG CO., LTD.
Product details
- Intended Use
- The Anti-MCV Regimen is an indirect solid-phase enzyme immunoassay (ELISA) that quantifies the concentration of anti-mutant citrulline waveform protein (MCV) IgG autoantibodies in human serum or plasma. This test can only be used in vitro to help diagnose rheumatoid arthritis.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.5775 類風濕性因子免疫試驗系統
- Import Information
- import
Dates and status
- Registration Date
- Nov 20, 2012
- Expiry Date
- Nov 20, 2022
- Cancellation Date
- Apr 12, 2024
Cancellation information
- Status
- Logged out
- Reason
- 許可證已逾有效期
About this record
Access comprehensive regulatory information for Ojie Anti-mutant citrulline waveform protein 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 1e0ae49e30260b53413e196a6a793df4 and manufactured by ORGENTEC DIAGNOSTIKA GMBH. The authorized representative in Taiwan is IN FUNG CO., LTD..
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