FDA Registration
Active
🇺🇸 United States
GENBIO
Reg #: 2027113
·
FEI: 2027113
·
Expires 2026
Products
9
Proprietary Names
12
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- GENBIO
- Registration Number
- 2027113
- FEI Number
- 2027113
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 15222 AVE. OF SCIENCE, Suite A
- City
- San Diego
- State
- CA
- ZIP
- 92128
- Country
- US
Regulatory Submissions
- 510(k) Number
- K911590
Owner / Operator
- Firm Name
- GenDx LLC
- Operator Number
- 2027113
- Address
- 15222 AVE OF SCIENCE, SUITE A, --
- City
- San Diego
- State
- CA
- Postal Code
- 92128
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagent, Borrelia Serological Reagent | LSR | Class 2 | Microbiology | No | 2008-08-24 |
| Reagent, Rickettsia Serological | LSQ | Class 1 | Microbiology | No | 2008-08-24 |
| Antisera, All Groups, Salmonella Spp. | GRM | Class 2 | Microbiology | No | 2008-08-25 |
| Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | LJZ | Class 1 | Microbiology | No | 2008-11-07 |
| Anti-Jcv Antibody Detection Assay | OYP | Class 2 | Microbiology | No | 2024-01-02 |
| Antigens, All, Leptospira Spp. | GRY | Class 2 | Microbiology | No | 2008-08-24 |
| Antisera, All Mycoplasma Spp. | GSA | Class 1 | Microbiology | No | 2023-05-12 |
| Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | LJM | Class 2 | Immunology | No | 2008-07-10 |
| Antiserum, Fluorescent, Q Fever | GPJ | Class 1 | Microbiology | No | 2012-06-14 |
Proprietary Names
ImmunoWELL Borrelia (Lyme)
ImmunoDOT Rickettsia typhi
ImmunoDOT Salmonella typhi
ImmunoWELL Mycoplasma Pneumoniae (IgG Antibody)
ImmunoDOT Rickettsia Conorii
ImmunoWELL anti-JCV IgG Test
ImmunoDOT Leptospira IgM
ImmunoFLOW Mycoplasma IgM Test
ImmunoDOT Autoimmunity Panel 1
ImmunoDOT Coxiella burnetii (Q Fever)
ImmunoWELL M. pneumoniae IgG
ImmunoWELL Mycoplasma Pneumoniae (IgM Antibody)
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only