FDA Registration
Active
🇺🇸 United States
Aptiva Celiac Disease IgA Reagent
Reg #: 2026994
·
FEI: 2026994
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- INOVA DIAGNOSTICS, INC.
- Registration Number
- 2026994
- FEI Number
- 2026994
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 9900 Old Grove Rd
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92131
- Country
- US
Regulatory Submissions
- 510(k) Number
- K193604
Owner / Operator
- Firm Name
- INOVA DIAGNOSTICS, INC.
- Operator Number
- 2026994
- Address
- 9900 OLD GROVE RD., --
- City
- San Diego
- State
- CA
- Postal Code
- 92131
- Country
- US
- Correspondent
- Constance Bridges
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Autoantibodies, Endomysial(Tissue Transglutaminase) | MVM | Class 2 | Immunology | No | 2021-09-02 |
| Antibodies, Gliadin | MST | Class 2 | Immunology | No | 2021-09-02 |
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2021-09-02 |
Proprietary Names
Aptiva Celiac Disease IgA Reagent
Establishment Types
Manufacture Medical Device