Taiwan FDA registration 47d3945f6f06d20ee2d6be65f97263dd
QUANTA Flash β2GP1 IgG Controls
TW: 因諾瓦β2-醣蛋白I免疫球蛋白G化學冷光免疫分析法對照組
Taiwan·Risk Class 2·MD·INOVA DIAGNOSTICS, INC.·Registered Apr 15, 2015 – Apr 15, 2025ExpiredRegistration details
- Analysis ID
- 47d3945f6f06d20ee2d6be65f97263dd
- License Form
- Ministry of Health Medical Device Import No. 027209
- Customs Code
- DHA05602720900
Company information
- Manufacturer
- INOVA DIAGNOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- Quality control of QUANTA Flash β2 GP1 IgG chemiluminescent immunoassay on BIO-FLASH instruments.
- 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
- Apr 15, 2015
- Expiry Date
- Apr 15, 2025
About this record
Access comprehensive regulatory information for QUANTA Flash β2GP1 IgG Controls in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 47d3945f6f06d20ee2d6be65f97263dd 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