FDA Registration
Active
🇺🇸 United States
BIO-ANALYSIS, INC.
Reg #: 2018685
·
FEI: 2018685
·
Expires 2026
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- BIO-ANALYSIS, INC.
- Registration Number
- 2018685
- FEI Number
- 2018685
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1701 BERKELEY ST.
- City
- Santa Monica
- State
- CA
- ZIP
- 90404
- Country
- US
Regulatory Submissions
- 510(k) Number
- K102841
Owner / Operator
- Firm Name
- BIO-ANALYSIS, INC.
- Operator Number
- 2018685
- Address
- 1701 BERKELEY ST., --
- City
- Santa Monica
- State
- CA
- Postal Code
- 90404
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Cortisol, Salivary | NHG | Class 2 | Clinical Chemistry | No | 2012-06-25 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2014-12-03 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2014-12-03 |
Proprietary Names
Pantex AM/PM Salivary Cortisol Enzyme Immunoassay
Pantex Salivary Direct Testosterone Enzyme Immunoassay (EIA) Kit, Pantex Sample Collection Device
Establishment Types
Manufacture Medical Device