FDA Registration
Active
🇺🇸 United States
Drug test
Reg #: 2029372
·
FEI: 1000306617
·
Expires 2025
Products
9
Proprietary Names
1
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- Diagnostic Automation/ Cortez Diagnostics Inc,.
- Registration Number
- 2029372
- FEI Number
- 1000306617
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 21250 Califa St Suite 102 and 116
- City
- Woodland Hills
- State
- CA
- ZIP
- 91367
- Country
- US
Regulatory Submissions
- 510(k) Number
- K033566
Owner / Operator
- Firm Name
- Diagnostic Automation /Cortez Diagnostics Inc.
- Operator Number
- 9011974
- Address
- 21250 Califa St,, SUITE 102 and 116
- City
- Woodland Hills
- State
- CA
- Postal Code
- 91367
- Country
- US
- Correspondent
- PAUL - SHAW
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2008-11-18 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2008-11-18 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2008-11-18 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2008-11-18 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2008-11-18 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2008-11-18 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2008-11-18 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2008-11-18 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2008-11-18 |
Proprietary Names
Drug test
Establishment Types
Manufacture Medical Device