Taiwan FDA registration b1308667b33e217848f47efe3ec575e6
QUANTA Lite RF IgM ELISA
TW: 因諾瓦類風濕因子免疫球蛋白M酵素連結免疫分析法檢驗試劑
Taiwan·Risk Class 2·MD·INOVA DIAGNOSTICS, INC.·Registered Dec 29, 2015 – Dec 29, 2025ExpiredRegistration details
- Analysis ID
- b1308667b33e217848f47efe3ec575e6
- License Form
- Ministry of Health Medical Device Import No. 028062
- Customs Code
- DHA05602806201
Company information
- Manufacturer
- INOVA DIAGNOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- This product uses Enzyme Linked Immunoassay to semi-quantitatively detect immunoglobulin M (IgM) rheumatoid factor (RF) antibodies in human serum samples.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C5775 Rheumatoid factor immunoassay system
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Dec 29, 2015
- Expiry Date
- Dec 29, 2025
About this record
Access comprehensive regulatory information for QUANTA Lite RF IgM ELISA in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b1308667b33e217848f47efe3ec575e6 and manufactured by INOVA DIAGNOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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