FDA Registration
Active
🇺🇸 United States
UCP COMPACT DRUG TEST CUPS
Reg #: 3036649420
·
FEI: 3036649420
·
Expires 2025
Products
11
Proprietary Names
2
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- HYSEN INC
- Registration Number
- 3036649420
- FEI Number
- 3036649420
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 201 E 5th St Ste 1900
- City
- Cincinnati
- State
- OH
- ZIP
- 45202
- Country
- US
Regulatory Submissions
- 510(k) Number
- K131811
Owner / Operator
- Firm Name
- Hysen Inc
- Operator Number
- 10092937
- Address
- 201 E Fifth Street, Suite 1900
- City
- Cincinnati
- State
- OH
- Postal Code
- 45202
- Country
- US
- Correspondent
- Song Han
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2025-06-27 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2025-06-27 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2025-06-27 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2025-06-27 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2025-06-27 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2025-06-27 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2025-06-27 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2025-06-27 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2025-06-27 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2025-06-27 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2025-06-27 |
Proprietary Names
UCP COMPACT DRUG TEST CUPS
UCP COMPACT DRUG TEST CARDS
Establishment Types
Repack or Relabel Medical Device