FDA Registration
Active
🇺🇸 United States
ABOUND Diagnostics, Inc
Reg #: 3030413233
·
FEI: 3030413233
·
Expires 2026
Products
26
Proprietary Names
0
Establishment Types
1
Classifications
26
Registration Details
- Registration Name
- ABOUND Diagnostics, Inc
- Registration Number
- 3030413233
- FEI Number
- 3030413233
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 12396 World Trade Drive, Suite 216,
- City
- San Diego
- State
- CA
- ZIP
- 92128
- Country
- US
Regulatory Submissions
- 510(k) Number
- K234152
Owner / Operator
- Firm Name
- ABOUND Diagnostics, Inc.
- Operator Number
- 10090000
- Address
- 12396 World Trade Drive, suite 216,
- City
- San Diego
- State
- CA
- Postal Code
- 92128
- Country
- US
- Correspondent
- Lee Mariano
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2026-01-20 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2026-01-20 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2026-01-20 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2026-01-20 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2026-01-20 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2026-01-20 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2026-01-20 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2026-01-20 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2026-01-20 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2026-01-20 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2026-01-20 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2026-01-20 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2026-01-20 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2026-01-17 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2026-01-17 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2026-01-17 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2026-01-17 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2026-01-17 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2026-01-17 |
| Thin Layer Chromatography, Morphine | DNK | Class 2 | Clinical Toxicology | No | 2026-01-17 |
| Test, Morphine, Over The Counter | NGI | Class 2 | Clinical Toxicology | No | 2026-01-17 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2026-01-17 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2026-01-17 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2026-01-17 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2026-01-17 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2026-01-21 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility