Taiwan FDA registration 4b28a5ba150382aad5a18c8d18c8890a
NOVA Lite DAPI ANCA Kit
TW: 因諾瓦抗嗜中性白血球細胞質抗體檢測試劑
Taiwan·Risk Class 2·MD·INOVA Diagnostics, Inc·Registered Aug 12, 2019 – Aug 12, 2024ExpiredRegistration details
- Analysis ID
- 4b28a5ba150382aad5a18c8d18c8890a
- License Form
- Ministry of Health Medical Device Import No. 032479
- Customs Code
- DHA05603247900
Company information
- Manufacturer
- INOVA Diagnostics, Inc
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- This product uses indirect immunofluorescent assay (IFA) to qualitatively and semi-quantitatively detect human serum anti-neutrophil cytoplasmic antibodies (ANCA).
- 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
- Aug 12, 2019
- Expiry Date
- Aug 12, 2024
About this record
Access comprehensive regulatory information for NOVA Lite DAPI ANCA Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4b28a5ba150382aad5a18c8d18c8890a and manufactured by INOVA Diagnostics, Inc. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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