Taiwan FDA registration 0ed13014188b329d0428886cf41b6fb8
Innova antinuclear antibody (mouse kidney and stomach) test group
TW: 因諾瓦抗核抗體(老鼠腎與胃)檢驗組
Taiwan·Risk Class 2·INOVA DIANOSTICS, INC.·Registered Apr 20, 2006 – Apr 20, 2026ExpiredRegistration details
- Analysis ID
- 0ed13014188b329d0428886cf41b6fb8
- Customs Code
- DHA00601644304
Company information
- Manufacturer
- INOVA DIANOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- 作為人類血清中之抗核抗體(anti-nuclear antibodies, ANA)、抗粒線體(anti-mitochondrial, AMA)、抗平滑肌(anti-smooth muscle, ASMA),及胃壁抗體(gastric parietal antibodies, GPA)之篩檢及半定量用.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.5100 抗核抗體免疫試驗系統
- Import Information
- import
Dates and status
- Registration Date
- Apr 20, 2006
- Expiry Date
- Apr 20, 2026
About this record
Access comprehensive regulatory information for Innova antinuclear antibody (mouse kidney and stomach) test group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 0ed13014188b329d0428886cf41b6fb8 and manufactured by INOVA DIANOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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