Taiwan FDA registration d9d5c2c7b79f0713958fb752c96e76d8
Innova antiphagocytic neutrocyte cytoplasmic antibody detection system
TW: 因諾瓦抗噬中性白血球細胞質抗體檢測系統
Registration details
- Analysis ID
- d9d5c2c7b79f0713958fb752c96e76d8
- Customs Code
- DHA00601535005
Company information
- Manufacturer
- INOVA DIANOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- Indirect immunofluorescent assay (IFA) was used for screening and semi-quantitative detection of anti-neutrophil cytoplasmic antibodies (ANCA) in human serological samples.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.5660 多發性自體抗體免疫試驗系統
- Import Information
- import
Dates and status
- Registration Date
- Dec 08, 2005
- Expiry Date
- Dec 08, 2025
About this record
Access comprehensive regulatory information for Innova antiphagocytic neutrocyte cytoplasmic antibody detection system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number d9d5c2c7b79f0713958fb752c96e76d8 and manufactured by INOVA DIANOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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