FDA Registration
Active
🇺🇸 United States
GENABIO DIAGNOSTICS INC
Reg #: 3016609999
·
FEI: 3016609999
·
Expires 2026
Products
26
Proprietary Names
0
Establishment Types
3
Classifications
26
Registration Details
- Registration Name
- GENABIO DIAGNOSTICS INC
- Registration Number
- 3016609999
- FEI Number
- 3016609999
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 19 Crosby Dr. Ste 220
- City
- Bedford
- State
- MA
- ZIP
- 01730
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240643
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
- Faye Cheng
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Paper, Obstetric Ph | LNW | Class 1 | Clinical Chemistry | No | 2023-08-14 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2024-09-19 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2024-09-23 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2024-03-05 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2024-03-05 |
| Reagent, Occult Blood | KHE | Class 2 | Hematology | No | 2023-11-28 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2023-08-31 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2023-08-31 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2023-08-31 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2023-08-31 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2023-10-31 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2023-10-31 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2024-09-19 |
| Immunoassay, Pregnanediol Glucuronide, Over The Counter | QKE | Class 1 | Clinical Chemistry | No | 2024-09-23 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2024-05-09 |
| Multi-Analyte Respiratory Virus Antigen Detection Test | SCA | Class 2 | Microbiology | No | 2025-05-13 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2023-10-31 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2023-10-31 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2023-10-31 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2023-10-31 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | 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 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2023-11-28 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2023-11-28 |
| Over-The-Counter Covid-19 Antigen Test | QYT | Class 2 | Microbiology | No | 2025-09-30 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Manufacture Medical Device