Taiwan FDA registration 88dcf939650133c642228636b031ce57
QUANTA Flash Jo-1 Reagents
TW: 因諾瓦Jo-1化學冷光免疫分析法反應試劑
Taiwan·Risk Class 2·MD·INOVA DIAGNOSTICS, INC.·Registered Jan 04, 2017 – Jan 04, 2027ActiveRegistration details
- Analysis ID
- 88dcf939650133c642228636b031ce57
- License Form
- Ministry of Health Medical Device Import No. 029181
- Customs Code
- DHA05602918101
Company information
- Manufacturer
- INOVA DIAGNOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- This product is used with BIO-FLASH instrument to semi-quantify anti-Jo-1 autoimmune antibodies in human serum by chemical cold light analysis.
- 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
- Jan 04, 2017
- Expiry Date
- Jan 04, 2027
About this record
Access comprehensive regulatory information for QUANTA Flash Jo-1 Reagents in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 88dcf939650133c642228636b031ce57 and manufactured by INOVA DIAGNOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Free DatabasePowered by Pure Global AI89,000+ Devices