FDA Registration
Active
🇺🇸 United States
HEALGEN SCIENTIFIC LLC
Reg #: 3009238284
·
FEI: 3009238284
·
Expires 2025
Products
6
Proprietary Names
0
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- HEALGEN SCIENTIFIC LLC
- Registration Number
- 3009238284
- FEI Number
- 3009238284
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3818 Fuqua St
- City
- Houston
- State
- TX
- ZIP
- 77047
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150356
Owner / Operator
- Firm Name
- HEALGEN SCIENTIFIC LLC
- Operator Number
- 10038461
- Address
- 3818 Fuqua Street
- City
- Houston
- State
- TX
- Postal Code
- 77047
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2015-05-15 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2015-05-15 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2015-05-15 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2015-05-15 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2015-05-15 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2015-05-15 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198