FDA Registration
Active
🇺🇸 United States
Precision DX Panel Cup Tests over the counter
Reg #: 3006305917
·
FEI: 3006305917
·
Expires 2025
Products
11
Proprietary Names
24
Establishment Types
1
Classifications
11
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
- K181768
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, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2021-09-09 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2021-09-09 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2021-09-09 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2021-09-09 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2021-09-09 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2021-09-09 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2021-09-09 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2021-09-09 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2021-09-09 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2021-09-09 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2021-09-09 |
Proprietary Names
Precision DX Panel Cup Tests over the counter
Precision Plus Panel Dip Card over the counter
Precision Plus Cup
Precision DX Panel Dip Tests over the counter
Precision Cup
Onescreen 1 Panel Dip Card
Reveal Cup
Discover Plus Dip Card
Precision Plus Panel Cup Tests over the counter
Drug Test Generic Dip Card
Precision Dip Card
Precision DX Dip Card
Precision DX Cup
Discover Dip Card
Discover Plus Cup
Discover Cup
Precision Plus Dip Card
Drug Test Generic Cup
K-Cup
OneScreen Dip Card
Reveal Dip Card
Onescreen 8 Panel Dip Card
Onescreen Cup
Reveal Mini Cup
Establishment Types
Manufacture Medical Device