FDA Registration
Active
🇺🇸 United States
QUANTA Flash Centromere Calibrators
Reg #: 2026994
·
FEI: 2026994
·
Expires 2025
Products
3
Proprietary Names
3
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
- K123880
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 |
|---|---|---|---|---|---|
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2014-02-10 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2014-02-10 |
| Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | LJM | Class 2 | Immunology | No | 2014-02-10 |
Proprietary Names
QUANTA Flash Centromere Calibrators
QUANTA Flash Centromere Reagents
QUANTA Flash Centromere Controls
Establishment Types
Manufacture Medical Device