Genabio Diagnostics Inc
Bedford, MA, US
GENABIO DIAGNOSTICS INC appears in FDA device records in Bedford, MA. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Genabio Diagnostics Inc between 2024 and 2025. The busiest year on record is 2024, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251753 | GenaCheck COVID-19 Rapid Self-Test | QYT | Substantially Equivalent | |
| K240545 | GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL) | LZA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3016609999 | 3016609999 | GENABIO DIAGNOSTICS INC | 19 Crosby Dr. Ste 220, Bedford, MA 01730 US | 2026 | and 16 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- JXNEnzyme Immunoassay, Propoxyphene
- QDOFentanyl And Other Opioid Protection Glove
- LAFGas Chromatography, Methamphetamine
- QKEImmunoassay, Pregnanediol Glucuronide, Over The Counter
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- LZCMedical Glove, Specialty
- OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- SCAMulti-Analyte Respiratory Virus Antigen Detection Test
- QYTOver-The-Counter Covid-19 Antigen Test
- LNWPaper, Obstetric Ph
- LZAPolymer Patient Examination Glove
- LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
- KHEReagent, Occult Blood
- NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter
- NGETest, Luteinizing Hormone (Lh), Over The Counter
- NGLTest, Opiates, Over The Counter
- LJXTest, Urine Leukocyte
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain