FDA Registration
Active
🇺🇸 United States
MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL
Reg #: 2249781
·
FEI: 3003204823
·
Expires 2025
Products
9
Proprietary Names
1
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- Healgen Scientific LLC
- Registration Number
- 2249781
- FEI Number
- 3003204823
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 603 Heron Dr Ste 4
- City
- Swedesboro
- State
- NJ
- ZIP
- 08085
- Country
- US
Regulatory Submissions
- 510(k) Number
- K992033
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, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2023-06-14 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2023-06-14 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2023-06-14 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2023-06-14 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2023-06-14 |
| Radioimmunoassay, Phencyclidine | LCL | Class U | Unknown | No | 2023-06-14 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2023-06-14 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2023-06-14 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2023-06-14 |
Proprietary Names
MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL
Establishment Types
Manufacture Medical Device