FDA Registration
Active
🇺🇸 United States
Rapid Reader
Reg #: 2249781
·
FEI: 3003204823
·
Expires 2025
Products
13
Proprietary Names
1
Establishment Types
1
Classifications
13
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
- K041696
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, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2023-05-17 |
| Fluorometer, For Clinical Use | KHO | Class 1 | Clinical Chemistry | No | 2023-05-17 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2023-05-17 |
| Liquid Chromatography, Morphine | DPK | Class 2 | Clinical Toxicology | No | 2023-05-17 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2023-05-17 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2023-05-17 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2023-05-17 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2023-05-17 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2023-05-17 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2023-05-17 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2023-05-17 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2023-05-17 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2023-05-17 |
Proprietary Names
Rapid Reader
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility