FDA Registration
Active
🇺🇸 United States
BIOCHECK, INC.
Reg #: 2953756
·
FEI: 3002564473
·
Expires 2026
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOCHECK, INC.
- Registration Number
- 2953756
- FEI Number
- 3002564473
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3451 Vincent Rd
- City
- Pleasant Hill
- State
- CA
- ZIP
- 94523
- Country
- US
Owner / Operator
- Firm Name
- BIOCHECK, INC.
- Operator Number
- 9033543
- Address
- 3451 Vincent Road, --
- City
- Pleasant Hill
- State
- CA
- Postal Code
- 94523
- Country
- US
- Correspondent
- Johanna - Saito
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Brain Trauma Assessment Test | QAT | Class 2 | Immunology | No | 2024-12-05 |
Proprietary Names
DxDATA Glial Fibrillary Acidic Protein (GFAP) CLIA Kit, DXDA-1003
DxDATA Protein Gene Product 9.5 (PGP 9.5) CLIA Kit, DXDA-1004
Establishment Types
Manufacture Device in the United States for Export Only