Taiwan FDA registration 36bbbb51f79e29fb93ce0d814ba2e55e
QUANTA Flash CCP3 Reagents
TW: 因諾瓦CCP3化學冷光免疫分析法反應試劑
Taiwan·Risk Class 2·MD·INOVA DIAGNOSTICS, INC.·Registered Nov 01, 2016 – Nov 01, 2026ActiveRegistration details
- Analysis ID
- 36bbbb51f79e29fb93ce0d814ba2e55e
- License Form
- Ministry of Health Medical Device Import No. 028940
- Customs Code
- DHA05602894001
Company information
- Manufacturer
- INOVA DIAGNOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- This product quantifies semi-quantitative anti-CCP3 antibodies in human serum by chemical cold light analysis. Combining other test results with clinical symptoms can help diagnose rheumatoid arthritis.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C5775 Rheumatoid factor immunoassay system
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Nov 01, 2016
- Expiry Date
- Nov 01, 2026
About this record
Access comprehensive regulatory information for QUANTA Flash CCP3 Reagents in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 36bbbb51f79e29fb93ce0d814ba2e55e and manufactured by INOVA DIAGNOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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