FDA Registration
Active
🇺🇸 United States
ANTIBODIES INCORPORATED
Reg #: 2914537
·
FEI: 2914537
·
Expires 2026
Products
7
Proprietary Names
6
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- ANTIBODIES INCORPORATED
- Registration Number
- 2914537
- FEI Number
- 2914537
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 25242 COUNTY ROAD 95
- City
- DAVIS
- State
- CA
- ZIP
- 95616
- Country
- US
Regulatory Submissions
- 510(k) Number
- K812314
Owner / Operator
- Firm Name
- Antibodies Incorporated
- Operator Number
- 2914537
- Address
- 25242 County Road 95, PO Box 1560
- City
- Davis
- State
- CA
- Postal Code
- 95616
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2017-09-28 |
| Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | DHN | Class 2 | Immunology | No | 2007-12-04 |
| Products, Red-Cell Lysing Products | GGK | Class 1 | Hematology | No | 2016-05-12 |
| Immunohistochemistry Reagents And Kits | NJT | Class 1 | Hematology | No | 2017-01-05 |
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2014-04-09 |
| Counter, Differential Cell | GKZ | Class 2 | Hematology | No | 2014-02-28 |
| Counter, Cell, Automated (Particle Counter) | GKL | Class 2 | Hematology | No | 2014-02-28 |
Proprietary Names
BD Sheath Additive
BD Detergent Solution Concentrate
AntiNuclear Antibody Test (ANA)
FACS LYSING SOLUTION
Anti-hTERT Antibody (SCD-A7)
CrithiDNA
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device