Taiwan FDA registration f13043b392643846ed075371e49b41b8
QUANTA Flash Ro60 Reagents
TW: 因諾瓦Ro60化學冷光免疫分析法反應試劑
Taiwan·Risk Class 2·MD·INOVA DIAGNOSTICS, INC.·Registered Oct 13, 2015 – Oct 13, 2025ExpiredRegistration details
- Analysis ID
- f13043b392643846ed075371e49b41b8
- License Form
- Ministry of Health Medical Device Import No. 027717
- Customs Code
- DHA05602771706
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-quantitatively detect anti-Ro-60 autoimmune antibodies 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
- Oct 13, 2015
- Expiry Date
- Oct 13, 2025
About this record
Access comprehensive regulatory information for QUANTA Flash Ro60 Reagents in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f13043b392643846ed075371e49b41b8 and manufactured by INOVA DIAGNOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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