Taiwan FDA registration 83399a700bfbb245168cc7358821af82
Innova anti-cardiac lipid antibody immunoglobulin M enzyme linkage face analysis test system
TW: 因諾瓦抗心脂質抗體免疫球蛋白M酵素連結面液分析法檢驗系統
Registration details
- Analysis ID
- 83399a700bfbb245168cc7358821af82
- Customs Code
- DHA00601533904
Company information
- Manufacturer
- INOVA DIANOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- Immunoenzyme method was used to carry out semi-quantitative detection of immunoglobulin M anticardiolipid antibody in human serum sample.
- 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
- Dec 08, 2005
- Expiry Date
- Dec 08, 2025
About this record
Access comprehensive regulatory information for Innova anti-cardiac lipid antibody immunoglobulin M enzyme linkage face analysis test system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 83399a700bfbb245168cc7358821af82 and manufactured by INOVA DIANOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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