Data / Medical devices / United States / Genabio Diagnostics Inc

Genabio Diagnostics Inc: FDA-registered device maker in Bedford, MA, United States, 11 510(k) clearances

Name: Genabio Diagnostics Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Genabio Diagnostics Inc is registered with the FDA (registration 3016609999) in Bedford, MA, United States. It lists 26 device types. The FDA files 11 510(k) clearances under its listings, the newest dated September 5, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Genabio Diagnostics Inc

FDA registration number: 3016609999
Address: 19 Crosby Dr. Ste 220, Bedford, MA, United States, 01730
Owner or operator: Genabio Diagnostics Inc. (10063095)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: August 14, 2023
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	JMT	1	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Amphetamine	DKZ	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Methadone	DJR	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Phencyclidine	LCM	U	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Propoxyphene	JXN	2	Repackager or relabeler	accessdata.fda.gov
Fentanyl And Other Opioid Protection Glove	QDO	1	Specification developer	accessdata.fda.gov
Gas Chromatography, Methamphetamine	LAF	2	Repackager or relabeler	accessdata.fda.gov
Immunoassay, Pregnanediol Glucuronide, Over The Counter	QKE	1	Specification developer	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Repackager or relabeler	accessdata.fda.gov
Medical Glove, Specialty	LZC	1	Specification developer	accessdata.fda.gov
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	OPJ	1	Specification developer	accessdata.fda.gov
Multi-Analyte Respiratory Virus Antigen Detection Test	SCA	2	Repackager or relabeler	accessdata.fda.gov
Over-The-Counter Covid-19 Antigen Test	QYT	2	Manufacturer, Specification developer	accessdata.fda.gov
Paper, Obstetric Ph	LNW	1	Specification developer	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Specification developer	accessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant Drugs	LFG	2	Repackager or relabeler	accessdata.fda.gov
Reagent, Occult Blood	KHE	2	Repackager or relabeler	accessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The Counter	NGA	1	Specification developer	accessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The Counter	NGE	1	Specification developer	accessdata.fda.gov
Test, Opiates, Over The Counter	NGL	2	Repackager or relabeler	accessdata.fda.gov
Test, Urine Leukocyte	LJX	1	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 5, 2025	K251753	GenaCheck COVID-19 Rapid Self-Test	QYT	Substantially Equivalent	Genabio Diagnostics, Inc.	accessdata.fda.gov
October 7, 2024	DEN240029	Healgen Rapid Check COVID-19/Flu A&B Antigen Test	SCA	Unknown	Healgen	accessdata.fda.gov
August 28, 2024	K240545	GenaCheck Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)	LZA	Substantially Equivalent	Genabio Diagnostics, Inc.	accessdata.fda.gov
June 21, 2024	K240643	MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream	LCX	Substantially Equivalent	Guangzhou Decheng Biotechnology Co., Ltd.	accessdata.fda.gov
October 26, 2023	K233417	AllTest Fentanyl Urine Test Cassette	NGL	Substantially Equivalent	Hangzhou AllTest Biotech Co., Ltd.	accessdata.fda.gov
June 16, 2023	K231045	Healgen URS Test Strips	LJX	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
January 4, 2023	K222907	Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate	LZA	Substantially Equivalent	Rmkh Glove (Cambodia) Co., Ltd.	accessdata.fda.gov
August 2, 2017	K163704	Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card	JXM	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
January 27, 2015	K143187	Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card)	DJG	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
June 6, 2014	K140546	HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST	LDJ	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
September 14, 2011	K110309	FOB ONE STEP RAPID TEST	KHE	Substantially Equivalent	Orient Gene Biotech	accessdata.fda.gov

Compare with other makers

Updated September 5, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.