FDA Registration
Active
🇺🇸 United States
Rapid TOX Cup II
Reg #: 1320738
·
FEI: 3000718556
·
Expires 2025
Products
10
Proprietary Names
1
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- Healgen Scientific LLC
- Registration Number
- 1320738
- FEI Number
- 3000718556
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 122 Smith Rd
- City
- KINDERHOOK
- State
- NY
- ZIP
- 12106
- Country
- US
Regulatory Submissions
- 510(k) Number
- K073078
Owner / Operator
- Firm Name
- HEALGEN SCIENTIFIC LLC
- Operator Number
- 10038461
- Address
- 3818 Fuqua Street
- City
- Houston
- State
- TX
- Postal Code
- 77047
- Country
- US
- Correspondent
- JIANQIU FANG
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2023-05-17 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2023-05-17 |
| Reagents, Test, Tetrahydrocannabinol | DKE | Class 2 | Clinical Toxicology | No | 2023-05-17 |
| High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs | LFI | Class 2 | Clinical Toxicology | No | 2023-05-17 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2023-05-17 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2023-05-17 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2023-05-17 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2023-05-17 |
| High Pressure Liquid Chromatography, Methamphetamine | LAG | Class 2 | Clinical Toxicology | No | 2023-05-17 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2023-05-17 |
Proprietary Names
Rapid TOX Cup II
Establishment Types
Manufacture Medical Device