FDA Registration
Active
🇺🇸 United States
Precision DX
Reg #: 3006305917
·
FEI: 3006305917
·
Expires 2025
Products
9
Proprietary Names
2
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- AMERICAN SCREENING CORPORATION
- Registration Number
- 3006305917
- FEI Number
- 3006305917
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9742 St. Vincent Street , Suite 100
- City
- Shreveport
- State
- LA
- ZIP
- 71106
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170049
Owner / Operator
- Firm Name
- American Screening, LLC
- Operator Number
- 10038017
- Address
- 9742 St. Vincent Street, Suite 100
- City
- Shreveport
- State
- LA
- Postal Code
- 71106
- Country
- US
- Correspondent
- Ron J Kilgarlin
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2018-06-18 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2018-06-18 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2018-06-18 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2018-06-18 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2018-06-18 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2018-06-18 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2018-06-18 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2018-06-18 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2018-06-18 |
Proprietary Names
Precision DX
Precision
Establishment Types
Repack or Relabel Medical Device