FDA Registration
Active
🇺🇸 United States
Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test
Reg #: 3008852306
·
FEI: 3008852306
·
Expires 2025
Products
13
Proprietary Names
4
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- Chemtron Biotech, Inc.
- Registration Number
- 3008852306
- FEI Number
- 3008852306
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9245 Brown Deer Rd Ste B
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232736
Owner / Operator
- Firm Name
- Chemtron Biotech, Inc.
- Operator Number
- 10035407
- Address
- 9245 Brown Deer Road
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2024-01-05 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2024-01-05 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2024-01-05 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2024-01-05 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2024-01-05 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2024-01-05 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2024-01-05 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2024-01-05 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2024-01-05 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2024-01-05 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2024-01-05 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2024-01-05 |
| Thin Layer Chromatography, Morphine | DNK | Class 2 | Clinical Toxicology | No | 2024-01-05 |
Proprietary Names
Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test
Chemtrue® Multi-Panel Drug Screen Dip Card Tests
Chemtrue® Multi-Panel Drug Screen Cup Tests
Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device