Taiwan FDA registration 957fd686cf3a38e2574741cf413f1f26
Innova β2-glycoprotein I immunoglobulin G enzyme linked immunoassay test system (unsterilized)
TW: 因諾瓦β2-醣蛋白I免疫球蛋白G酵素連結免疫分析法檢驗系統(未滅菌)
Taiwan·Risk Class 1·INOVA DIANOSTICS, INC.·Registered Dec 01, 2005 – Dec 01, 2025ExpiredRegistration details
- Analysis ID
- 957fd686cf3a38e2574741cf413f1f26
- Customs Code
- DHA04400218301
Company information
- Manufacturer
- INOVA DIANOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- Semi-quantitative detection of β2 GPI IgG antibodies in human serum samples by immunoenzyme method (ELISA).
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.5430 β-2-醣蛋白I免疫試驗系統
- Import Information
- import
Dates and status
- Registration Date
- Dec 01, 2005
- Expiry Date
- Dec 01, 2025
About this record
Access comprehensive regulatory information for Innova β2-glycoprotein I immunoglobulin G enzyme linked immunoassay test system (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 957fd686cf3a38e2574741cf413f1f26 and manufactured by INOVA DIANOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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