FDA Registration
Active
🇺🇸 United States
ANA PCNA Pattern
Reg #: 2026994
·
FEI: 2026994
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
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 Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2013-09-12 |
Proprietary Names
ANA PCNA Pattern
Pemphigus Positive Control
Atypical ANCA Positive
Pemphigus Positive
Pancreatic Islet Cell Pos. Ctl.
Endomysial (Celiac) Positive
Mitochondrial (AMA) Pattern
Gastric Parietal Cell (GPA) Pattern
Yo (Purkinje Cell) Pos. Ctl.
Establishment Types
Manufacture Medical Device