FDA Registration
Active
🇺🇸 United States
Chemtron Biotech, Inc.
Reg #: 3008852306
·
FEI: 3008852306
·
Expires 2026
Products
24
Proprietary Names
10
Establishment Types
3
Classifications
24
Registration Details
- Registration Name
- Chemtron Biotech, Inc.
- Registration Number
- 3008852306
- FEI Number
- 3008852306
- Status
- Active
- Expiry Year
- 2026
- 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 |
|---|---|---|---|---|---|
| Test, Morphine, Employment And Insurance Testing, Exempt | PVG | Class 2 | Clinical Toxicology | No | 2022-03-01 |
| Thin Layer Chromatography, Morphine | DNK | Class 2 | Clinical Toxicology | No | 2024-01-05 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2024-01-05 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2024-01-05 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2024-01-05 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2024-01-05 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2024-01-05 |
| Enzyme Immunoassay, Cannabinoids | LDJ | 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, Phencyclidine | LCM | Class U | Unknown | No | 2024-01-05 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2024-01-05 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2024-01-05 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2024-01-05 |
| Test, Barbiturate, Employment And Insurance Testing, Exempt | PUY | Class 2 | Clinical Toxicology | No | 2022-03-01 |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | PVJ | Class 2 | Clinical Toxicology | No | 2022-03-01 |
| Test, Methamphetamine, Employment And Insurance Testing, Exempt | PVD | Class 2 | Clinical Toxicology | No | 2022-03-01 |
| Test, Benzodiazepine, Employment And Insurance Testing, Exempt | PUZ | Class 2 | Clinical Toxicology | No | 2022-03-01 |
| Component, Cast | LGF | Class 1 | Orthopedic | No | 2015-07-14 |
| Test, Methadone, Employment And Insurance Testing, Exempt | PVE | Class 2 | Clinical Toxicology | No | 2022-03-01 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2015-07-14 |
| Test, Opiates, Employment And Insurance Testing, Exempt | PVH | Class 2 | Clinical Toxicology | No | 2022-03-01 |
| Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt | PVA | Class 2 | Clinical Toxicology | No | 2022-03-01 |
| Test, Amphetamine, Employment And Insurance Testing, Exempt | PUX | Class 2 | Clinical Toxicology | No | 2022-03-01 |
Proprietary Names
Chemtrue® Multi-Panel Drug Screen Cup Tests
Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test
Chemtrue® Multi-Panel Drug Screen Dip Card Tests
Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test
Chemtrue Drug Screen Cup Tests
Chemtrue Multi-Panel Drug Screen Tests
Chemtrue hCG Pregnancy Urine Test
DrugSmart Dip
DrugSmart Cup
Chemtrue
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device