FDA Registration
Active
🇺🇸 United States
QUANTA Flash CTD Screen Plus Controls
Reg #: 2026994
·
FEI: 2026994
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
2
Classifications
1
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
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 |
|---|---|---|---|---|---|
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2020-03-05 |
Proprietary Names
QUANTA Flash CTD Screen Plus Controls
Aptiva Celiac Disease IgA Controls
Aptiva Celiac Disease IgG Controls
QUANTA Flash aPL Multi Controls
Aptiva APS IgM Controls
Aptiva CTD Essential Controls
Aptiva APS IgG Controls
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device