Taiwan FDA registration cbf6a2dece23e6c3fba77832d8b1c04b
QUANTA Flash aCL IgG Controls
TW: 因諾瓦抗心脂質抗體免疫球蛋白G化學冷光免疫分析法對照組
Taiwan·Risk Class 2·MD·INOVA DIAGNOSTICS, INC.·Registered Feb 10, 2015 – Feb 10, 2025ExpiredRegistration details
- Analysis ID
- cbf6a2dece23e6c3fba77832d8b1c04b
- License Form
- Ministry of Health Medical Device Import No. 027068
- Customs Code
- DHA05602706808
Company information
- Manufacturer
- INOVA DIAGNOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- Used in BIO-FLASH instruments as quality control for QUANTA Flash aCL IgG chemiluminescent immunoassay.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1660 Quality Control Materials (Analytical and Non-Analytical)
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Feb 10, 2015
- Expiry Date
- Feb 10, 2025
About this record
Access comprehensive regulatory information for QUANTA Flash aCL IgG Controls in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number cbf6a2dece23e6c3fba77832d8b1c04b and manufactured by INOVA DIAGNOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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