FDA Registration
Active
🇺🇸 United States
Status First DOA 10
Reg #: 2246703
·
FEI: 2246703
·
Expires 2025
Products
10
Proprietary Names
3
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- PRINCETON BIOMEDITECH CORP.
- Registration Number
- 2246703
- FEI Number
- 2246703
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4242 U.S. Hwy. 1
- City
- Monmouth Jct
- State
- NJ
- ZIP
- 08852
- Country
- US
Regulatory Submissions
- 510(k) Number
- K062575
Owner / Operator
- Firm Name
- PRINCETON BIOMEDITECH CORP.
- Operator Number
- 2246703
- Address
- 4242 U.S. HIGHWAY 1, --
- City
- Monmouth Junction
- State
- NJ
- Postal Code
- 08852
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagents, Test, Tetrahydrocannabinol | DKE | Class 2 | Clinical Toxicology | No | 2007-12-12 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2007-12-12 |
| High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs | LFI | Class 2 | Clinical Toxicology | No | 2007-12-12 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2007-12-12 |
| High Pressure Liquid Chromatography, Methamphetamine | LAG | Class 2 | Clinical Toxicology | No | 2007-12-12 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2007-12-12 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2007-12-12 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2007-12-12 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2007-12-12 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2007-12-12 |
Proprietary Names
Status First DOA 10
AccuSign RC DOA 10 (MET/OPI/COC/THC
StatusFirst DOA10/StatusFirst DOA5
Establishment Types
Manufacture Medical Device