Taiwan FDA registration cb191a78af68e30cef0b3527b9fd9e7e
QUANTA Flash dsDNA Reagents
TW: 因諾瓦dsDNA化學冷光免疫分析法反應試劑
Taiwan·Risk Class 2·MD·INOVA DIAGNOSTICS, INC.·Registered Jun 21, 2016 – Jun 21, 2026ExpiredRegistration details
- Analysis ID
- cb191a78af68e30cef0b3527b9fd9e7e
- License Form
- Ministry of Health Medical Device Import No. 028447
- Customs Code
- DHA05602844708
Company information
- Manufacturer
- INOVA DIAGNOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- This product quantifies anti-dsDNA antibodies in human serum by chemical cold light analysis. Combining other test results with clinical symptoms can help diagnose systemic lupus erythematosus.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C5100 Antinuclear antibody immunoassay system
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jun 21, 2016
- Expiry Date
- Jun 21, 2026
About this record
Access comprehensive regulatory information for QUANTA Flash dsDNA Reagents in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number cb191a78af68e30cef0b3527b9fd9e7e and manufactured by INOVA DIAGNOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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