Taiwan FDA registration fa925deaa5de7606c3bbecc78109acbc
QUANTA Flash Sm Controls
TW: 因諾瓦Sm化學冷光免疫分析法對照組
Taiwan·Risk Class 2·MD·INOVA DIAGNOSTICS, INC.·Registered Mar 03, 2015 – Mar 03, 2025ExpiredRegistration details
- Analysis ID
- fa925deaa5de7606c3bbecc78109acbc
- License Form
- Ministry of Health Medical Device Import No. 027083
- Customs Code
- DHA05602708304
Company information
- Manufacturer
- INOVA DIAGNOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- This product is used in QUANTA Flash Sm chemical cold light immunoassay for semi-quantitative detection and analysis of Sm antibodies in human serum samples.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1660 Quality Control Materials (Analytical and Non-Analytical)
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Mar 03, 2015
- Expiry Date
- Mar 03, 2025
About this record
Access comprehensive regulatory information for QUANTA Flash Sm Controls in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number fa925deaa5de7606c3bbecc78109acbc and manufactured by INOVA DIAGNOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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