FDA Registration
Active
🇺🇸 United States
Number One multi-Panel Drug Test Cup
Reg #: 3004987297
·
FEI: 3004987297
·
Expires 2025
Products
11
Proprietary Names
3
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- UCP BIOSCIENCES, INC.
- Registration Number
- 3004987297
- FEI Number
- 3004987297
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1900 Mccarthy Blvd Ste 204
- City
- Milpitas
- State
- CA
- ZIP
- 95035
- Country
- US
Regulatory Submissions
- 510(k) Number
- K131811
Owner / Operator
- Firm Name
- UCP BIOSCIENCES, INC.
- Operator Number
- 9069635
- Address
- 1900 McCarthy Blvd STE 204, --
- City
- Milpitas
- State
- CA
- Postal Code
- 95035
- Country
- US
- Correspondent
- Shawn - Lee
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2013-12-15 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2013-12-15 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2013-12-15 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2013-12-15 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2013-12-15 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2013-12-15 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2013-12-15 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2013-12-15 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2013-12-15 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2013-12-15 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2013-12-15 |
Proprietary Names
Number One multi-Panel Drug Test Cup
ClearRapids Multi-Panel Drug Test Cup
UCP Compact Drug Tests
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility