Taiwan FDA registration 053b689ee111d3b1341234c2425d9dac
QUANTA Flash SS-B Reagents
TW: 因諾瓦SS-B化學冷光免疫分析法反應試劑
Taiwan·Risk Class 2·MD·INOVA DIAGNOSTICS, INC.·Registered Oct 15, 2015 – Oct 15, 2025ExpiredRegistration details
- Analysis ID
- 053b689ee111d3b1341234c2425d9dac
- License Form
- Ministry of Health Medical Device Import No. 027881
- Customs Code
- DHA05602788106
Company information
- Manufacturer
- INOVA DIAGNOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- Combined with BIO-FLASH instrument for semi-quantitative antibodies against Schrögelian syndrome type B (SS-B) antigen 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
- Oct 15, 2015
- Expiry Date
- Oct 15, 2025
About this record
Access comprehensive regulatory information for QUANTA Flash SS-B Reagents in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 053b689ee111d3b1341234c2425d9dac and manufactured by INOVA DIAGNOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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