Taiwan FDA registration 8bc8991f17fafc7ba24399044f39cf6d
Innova mitochondrial M2 enzyme link immunoassay detection system
TW: 因諾瓦粒線體M2酵素連結免疫分析法檢測系統
Registration details
- Analysis ID
- 8bc8991f17fafc7ba24399044f39cf6d
- Customs Code
- DHA00601635405
Company information
- Manufacturer
- INOVA DIANOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- Enzyme Linked Immunoassay (ELISA) was used for semi-quantitative detection of Mitochondria antibodies in human serological samples.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.5510 免疫球蛋白A,G,M,D及E免疫試驗系統
- Import Information
- import
Dates and status
- Registration Date
- Apr 14, 2006
- Expiry Date
- Apr 14, 2011
- Cancellation Date
- Nov 20, 2012
Cancellation information
- Status
- Logged out
- Reason
- 許可證已逾有效期
About this record
Access comprehensive regulatory information for Innova mitochondrial M2 enzyme link immunoassay detection system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8bc8991f17fafc7ba24399044f39cf6d and manufactured by INOVA DIANOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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