Taiwan FDA registration 3c811c9a89818b7d4934db2940fb60d5
AtheNa Multi-Lyte GBM (Autoimmune Vasculitis) Plus Test System
TW: 宙斯自體免疫性血管炎檢驗系統
Taiwan·Risk Class 2·MD·ZEUS SCIENTIFIC, INC.·Registered Mar 17, 2016 – Mar 17, 2026ExpiredRegistration details
- Analysis ID
- 3c811c9a89818b7d4934db2940fb60d5
- License Form
- Ministry of Health Medical Device Import No. 028305
- Customs Code
- DHA05602830501
Company information
- Manufacturer
- ZEUS SCIENTIFIC, INC.
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- This product targets quantitative or semi-quantitative detection of IgG antibodies to 3 different antigens (glomerular basement membrane, myeloperoxidase and protease 3) in human serum.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C5660 Multiple autologous antibody immunoassay system
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Mar 17, 2016
- Expiry Date
- Mar 17, 2026
About this record
Access comprehensive regulatory information for AtheNa Multi-Lyte GBM (Autoimmune Vasculitis) Plus Test System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3c811c9a89818b7d4934db2940fb60d5 and manufactured by ZEUS SCIENTIFIC, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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