FDA Registration
Active
🇺🇸 United States
ACCU NEWS Multi-Drug Screen Test, Multi-Drug 5 Test Panel (THC-COC-MET-AMP-MOP)
Reg #: 3022137053
·
FEI: 3022137053
·
Expires 2025
Products
5
Proprietary Names
5
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- CorDx Inc.
- Registration Number
- 3022137053
- FEI Number
- 3022137053
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3719 North Peachtree Road, Suite 200
- City
- Chamblee
- State
- GA
- ZIP
- 30341
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152590
Owner / Operator
- Firm Name
- CorDx
- Operator Number
- 10050914
- Address
- 9540 Waples St Unit C
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
- Correspondent
- Amber Wen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2017-06-26 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2017-06-26 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2017-06-26 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2017-06-26 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2017-06-26 |
Proprietary Names
ACCU NEWS Multi-Drug Screen Test, Multi-Drug 5 Test Panel (THC-COC-MET-AMP-MOP)
ACCU NEWS Single Drug Screen Test, THC Test
ACCU NEWS Single Drug Screen Test, COC Test
ACCU NEWS Drug Test Cup, Multi Drug 5 Urine Cup (THC-COC-MET-AMP-MOP)
CorDx Tyfast Multi-Drug Screen Test
Establishment Types
Manufacture Medical Device