FDA Registration
Active
🇺🇸 United States
GenaCheck Rapid Self-Test Kit for Twelve (12) Drugs
Reg #: 3016609999
·
FEI: 3016609999
·
Expires 2025
Products
11
Proprietary Names
2
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- GENABIO DIAGNOSTICS INC
- Registration Number
- 3016609999
- FEI Number
- 3016609999
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 19B Crosby Dr. Ste 220
- City
- Bedford
- State
- MA
- ZIP
- 01730
- Country
- US
Regulatory Submissions
- 510(k) Number
- K163704
Owner / Operator
- Firm Name
- Genabio Diagnostics Inc.
- Operator Number
- 10063095
- Address
- 19B Crosby Dr. Ste 220
- City
- Bedford
- State
- MA
- Postal Code
- 01730
- Country
- US
- Correspondent
- weike mo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2023-10-31 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2023-10-31 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2023-10-31 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2023-10-31 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2023-10-31 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2023-10-31 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2023-10-31 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2023-10-31 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2023-10-31 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2023-10-31 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2023-10-31 |
Proprietary Names
GenaCheck Rapid Self-Test Kit for Twelve (12) Drugs
GenaCheck Rapid Self-Test Kit for Five (5) Drugs
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198