Taiwan FDA registration d00fb5f05a6453c66ee150ae4e280a55
QUANTA Flash Scl-70 Reagents
TW: 因諾瓦Scl-70化學冷光免疫分析法反應試劑
Taiwan·Risk Class 2·MD·INOVA DIAGNOSTICS, INC.·Registered Nov 18, 2016 – Nov 18, 2026ActiveRegistration details
- Analysis ID
- d00fb5f05a6453c66ee150ae4e280a55
- License Form
- Ministry of Health Medical Device Import No. 028955
- Customs Code
- DHA05602895501
Company information
- Manufacturer
- INOVA DIAGNOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- This product uses chemical cold light analysis to semi-quantify anti-Scl-70 autoimmune antibody in human serum.
- 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
- Nov 18, 2016
- Expiry Date
- Nov 18, 2026
About this record
Access comprehensive regulatory information for QUANTA Flash Scl-70 Reagents in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number d00fb5f05a6453c66ee150ae4e280a55 and manufactured by INOVA DIAGNOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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