Taiwan FDA registration cb47fcb9f692ca46377c4569bdcacb4e
QUANTA Flash aCL IgM Controls
TW: 因諾瓦抗心脂質抗體免疫球蛋白M化學冷光免疫分析法對照組
Taiwan·Risk Class 2·MD·INOVA DIAGNOSTICS, INC.·Registered Oct 07, 2015 – Oct 07, 2025ExpiredRegistration details
- Analysis ID
- cb47fcb9f692ca46377c4569bdcacb4e
- License Form
- Ministry of Health Medical Device Import No. 027708
- Customs Code
- DHA05602770805
Company information
- Manufacturer
- INOVA DIAGNOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- The BIO-FLASH instrument is the quality control of the QUANTA Flash aCL IgM chemiluminescent immunoassay.
- 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
- Oct 07, 2015
- Expiry Date
- Oct 07, 2025
About this record
Access comprehensive regulatory information for QUANTA Flash aCL IgM Controls in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number cb47fcb9f692ca46377c4569bdcacb4e and manufactured by INOVA DIAGNOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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