Data / Medical devices / United States / Healgen Scientific LLC

Healgen Scientific LLC: FDA-registered device maker in Houston, TX, United States, 33 510(k) clearances

Name: Healgen Scientific LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Healgen Scientific LLC is registered with the FDA (registration 3009238284) in Houston, TX, United States. It lists 77 device types. The FDA files 33 510(k) clearances under its listings, the newest dated April 13, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Healgen Scientific LLC

FDA registration number: 3009238284
Address: 3818 Fuqua St, Houston, TX, United States, 77047
Owner or operator: HEALGEN SCIENTIFIC LLC (10038461)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: October 16, 2011
Registered through: 2027
Brand names listed: Easy Healthcare Corporation easy@Home Urinary Tract Infection Test, External Controls Healgen Rapid Check COVID-19/Flu A&B Antigen Test Pro, HEAL-CHECK Pee Cup, Heal-Check Rapid COVID-19 Antigen Self-Test, Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Home Urine Drug Testing Dip Card, Healgen Accurate Urine Drug Screen Dip Card, Healgen Accurate Urine Drug Screening Dip Card and more

Devices it lists

Device	Product code	Class	Role	Source
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	JMA	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	DIC	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Analyzer, Enzyme, For Clinical Use	JJI	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	GQG	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Antigens, All Groups, Streptococcus Spp.	GTY	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Automated Urinalysis System	KQO	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	JJB	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Blood, Occult, Colorimetric, In Urine	JIO	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Clinical Sample Concentrator	JJH	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Colorimeter, Photometer, Spectrophotometer For Clinical Use	JJQ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Container, Specimen, Non-Sterile	NNI	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Control, Fecal Occult Blood	OSL	2	Complaint file establishment	accessdata.fda.gov
Coronavirus Antigen Detection Test System.	QKP	N	Complaint file establishment	accessdata.fda.gov
Covid-19 Multi-Analyte Antigen Device	QMN	N	Complaint file establishment, Specification developer	accessdata.fda.gov
Device, Fertility Diagnostic, Proceptive	LHD	U	Complaint file establishment, Specification developer	accessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	JMT	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	CDM	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)	CEN	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Amphetamine	DKZ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Methadone	DJR	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Nicotine And Nicotine Metabolites	MKU	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Phencyclidine	LCM	U	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Propoxyphene	JXN	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	QKR	N	Complaint file establishment, Specification developer	accessdata.fda.gov
Gas Chromatography, Methamphetamine	LAF	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	JIR	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Kit, Direct Antigen, Negative Control	MKA	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Kit, Direct Antigen, Positive Control	MJZ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	JIL	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Multi-Analyte Respiratory Virus Antigen Detection Test	SCA	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Nephelometer, For Clinical Use	JQX	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Over-The-Counter Covid-19 Antigen Test	QYT	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Paper, Obstetric Ph	LNW	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant Drugs	LFG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Reagent, Coronavirus Serological	QKO	N	Complaint file establishment	accessdata.fda.gov
Reagent, Occult Blood	KHE	2	Complaint file establishment	accessdata.fda.gov
Reagents, 2019-Novel Coronavirus Nucleic Acid	QJR	N	Complaint file establishment, Specification developer	accessdata.fda.gov
Refractometer For Clinical Use	JRE	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings	QVF	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test System, Nicotine, Cotinine, Metabolites	MRS	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Amphetamine, Employment And Insurance Testing, Exempt	PUX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Amphetamine, Over The Counter	NFT	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Barbiturate, Employment And Insurance Testing, Exempt	PUY	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Barbiturate, Over The Counter	PTH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Benzodiazepine, Employment And Insurance Testing, Exempt	PUZ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Benzodiazepine, Over The Counter	NFV	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Cannabinoid, Employment And Insurance Testing, Exempt	PVJ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Cannabinoid, Over The Counter	NFW	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	PVA	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The Counter	NFY	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Codeine, Employment And Insurance Testing, Exempt	PVB	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The Counter	NGA	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The Counter	NGE	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Methadone, Employment And Insurance Testing, Exempt	PVE	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Methadone, Over The Counter	PTG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Methamphetamine, Employment And Insurance Testing, Exempt	PVD	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Methamphetamine, Over The Counter	NGG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Methaqualone, Employment And Insurance Testing, Exempt	PVF	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Morphine, Employment And Insurance Testing, Exempt	PVG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Opiates, Employment And Insurance Testing, Exempt	PVH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Opiates, Over The Counter	NGL	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Phencyclidine (Pcp), Over The Counter	NGM	U	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Propoxyphene, Employment And Insurance Testing, Exempt	PVI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Propoxyphene, Over The Counter	QBF	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt	PVK	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Tricyclic Antidepressants, Over The Counter	QAW	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Urine Leukocyte	LJX	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Thin Layer Chromatography, Methamphetamine	DJC	2	Complaint file establishment, Specification developer	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
April 13, 2026	K260095	Heal-Check Rapid COVID-19 Antigen Self-Test	QYT	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
March 16, 2026	K253705	Healgen® Accurate Oral Fluid Drug Test	DJC	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
February 12, 2026	K252523	Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test	NFW	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
December 23, 2025	K253567	Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card	NGL	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
December 23, 2025	K251800	Healgen® URS Test Strips	JMT	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
December 17, 2024	K243365	Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup	NGL	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
October 7, 2024	DEN240029	Healgen Rapid Check COVID-19/Flu A&B Antigen Test	SCA	Unknown	Healgen	accessdata.fda.gov
May 13, 2024	K240949	Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)	NGL	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
April 19, 2024	K232377	Healgen Rapid COVID-19 Antigen Test	QVF	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
April 12, 2024	K240686	Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card	NGL	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
June 16, 2023	K231045	Healgen URS Test Strips	LJX	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
March 17, 2023	K223162	Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT	LDJ	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
August 30, 2022	K221871	Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx	NFT	Substantially Equivalent	Healstone Biotech, Inc.	accessdata.fda.gov
June 30, 2022	K212418	hCG One Step Pregnancy Test	LCX	Substantially Equivalent	Healstone Biotech, Inc.	accessdata.fda.gov
March 16, 2022	K212623	Healgen Strep A Rapid Test Strip (Throat Swab)	GTY	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
August 7, 2019	K191841	Accurate Multi Panel Drug Urine Test Cup	NFT	Substantially Equivalent	Healstone Biotech, Inc.	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
May 23, 2016	K153597	Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card	JXM	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
September 9, 2015	K152269	Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)	DKZ	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
August 18, 2015	K151348	Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)	LFG	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
August 13, 2015	K151642	Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card	JXM	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
May 13, 2015	K150356	Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card	JXM	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
April 24, 2015	K150791	Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)	DIS	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
March 4, 2015	K150096	Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)	LAF	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
October 16, 2014	K142280	Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)	DJG	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
July 17, 2014	K141647	HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)	DIO	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
April 10, 2013	K123703	HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)	LCX	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
April 17, 2012	K111999	HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL	JIO	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
July 28, 2011	K103574	PREGNANCY ONE STEP RAPID TEST	LCX	Substantially Equivalent	Lehnus & Associates Consulting	accessdata.fda.gov
November 20, 2002	K021789	QUICKLAB RSV	GQG	Substantially Equivalent	Integrated Biotechnology Corp.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 22, 2024	95248	Class II	Ongoing	Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color change of the pad a	The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products have shown reduced sensitivity, or potential false negative results for the detection of urinary protein by way of uneven color fading on the total protein test pad. This could lead to a delay in the identification of potential kidney diseases, thei	accessdata.fda.gov

Compare with other makers

Updated April 13, 2026. 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.