Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009238284

FEI Number

3009238284

Entity Name

HEALGEN SCIENTIFIC LLC

City/State/Country

Houston, TX, US

Establishment Address

3818 Fuqua St, Houston, TX 77047, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

HEALGEN SCIENTIFIC LLC (Owner Number: 10038461)

Owner / Operator Contact Address

3818 Fuqua Street, Houston, TX 77047, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Healgen COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) Healgen Accurate Urine Drug Screen Dip Card Healgen Accurate Home Urine Drug Test Dip Card Healgen Accurate Home Multi-Drug Urine Test Cup Healgen Accurate Multi-Drug Urine Drug Screening Cup Healgen Accurate Multi-Drug Urine Drug Screen Cup Healgen Accurate Home Multi-Drug Urine Testing Cup Healgen Rapid Check COVID-19 Antigen Test Healgen Rapid Check RSV Antigen Test Cassette Healgen® URS Test Strips Healgen Scientific LLC Healgen PH test HEAL-CHECK Pee Cup Healgen Rapid Check Strep A Antigen Test Healgen Scientific LLC Strep A Rapid Test Strip (Throat Swab) Healgen Scientific LLC Healgen Scientific LLC Healgen® Accurate Fentanyl Rapid Test Cassette (Urine) Healgen® Accurate Rapid Fentanyl Test Strip (Urine) Healgen® Accurate Rapid Fentanyl Test Cassette (Urine) Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine) Healgen® Accurate Fentanyl Rapid Test Strip (Urine) Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine) Healgen Scientific LLC URcheck UTI Test Strip Easy Healthcare Corporation easy@Home Urinary Tract Infection Test Healgen URS Test Strips Healgen Scientific LLC, URcheck URS Test Strip Heal-Check Rapid COVID-19 Antigen Self-Test Siemens Clinitest Healgen Scientific Healgen Rapid Check Flu A&B/COVID-19 Antigen Test Pro Healgen Rapid Check COVID-19/Flu A&B Antigen Test PRO Healgen Rapid Check COVID-19 / Flu A&B Antigen Test Healgen Rapid Check Flu A&B/COVID-19 Antigen Test Healgen Accurate Urine Drug Screen Dip Card Healgen Accurate Home Urine Drug Test Dip Card Healgen Scientific LLC Healgen Scientific LLC., FSH Menopause Test Midstream Healgen Scientific LLC., FSH Menopause Test Cassette Healgen Scientific LLC., FSH Menopause Test Strip Healgen® Accurate Oral Fluid Drug Test COT/THC Healgen® Accurate Oral Fluid Drug Test Healgen URcheck Urinalysis Reagent Strips Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} URcheck Urinalysis Reagent Test Strip Healgen Scientific LLC Healgen 500 Urine Analyzer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2021-04-30
QMN	Covid-19 Multi-Analyte Antigen Device	Unknown	Class N	N/A	2024-07-16
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2026-04-28
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2026-04-28
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2026-04-28
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2026-04-28
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2026-04-28
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2026-04-28
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2026-04-28
MRS	Test System, Nicotine, Cotinine, Metabolites	Clinical Toxicology	Class 1	862.3220	2019-01-03
PVF	Test, Methaqualone, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3630	2018-12-19
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2015-08-24
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2015-08-24
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2015-08-24
DIC	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	Clinical Toxicology	Class 2	862.3040	2020-10-20
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2024-04-22
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2024-04-22
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2024-04-22
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2024-04-22
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2024-04-22
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-04-22
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2024-04-22
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2024-04-22
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2024-04-22
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2024-04-22
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2024-04-22
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3870	2018-12-19
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2025-02-28
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2025-02-28
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2025-02-28
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2025-02-28
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2025-02-28
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2025-02-28
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2025-02-28
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2025-02-28
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2025-02-28
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2025-02-28
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2025-02-28
QVF	Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings	Microbiology	Class 2	866.3982	2024-04-22
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2023-05-17
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2026-01-12
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2026-01-12
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2016-07-01
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-05-12
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2011-10-16
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2015-03-24
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2015-03-24
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2015-03-24
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2015-03-24
LNW	Paper, Obstetric Ph	Clinical Chemistry	Class 1	862.1550	2021-11-19
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2023-02-03
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2025-11-27
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2022-03-17
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2017-09-08
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2011-10-16
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2011-10-16
JQX	Nephelometer, For Clinical Use	Clinical Chemistry	Class 1	862.2700	2011-10-16
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-05-17
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2016-05-24
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2016-05-24
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2016-05-24
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2016-05-24
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2016-05-24
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2016-05-24
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2016-05-24
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2016-05-24
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2016-05-24
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2017-10-17
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2017-10-17
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2017-10-17
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2017-10-17
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2017-10-17
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2017-10-17
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2017-10-17
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2017-10-17
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2017-10-17
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2017-10-17
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2017-10-17
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2011-10-16
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2022-03-17
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2024-01-29
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2024-01-29
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2015-06-15
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2015-06-15
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2015-06-15
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2020-03-20
PVK	Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3910	2018-12-19
QYT	Over-The-Counter Covid-19 Antigen Test	Microbiology	Class 2	866.3984	2026-04-21
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2015-08-18
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2020-07-28
SCA	Multi-Analyte Respiratory Virus Antigen Detection Test	Microbiology	Class 2	866.3987	2024-10-08
PVG	Test, Morphine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3640	2018-12-19
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2022-06-15
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2026-01-12
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2026-01-12
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2026-01-12
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2026-01-12
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2026-01-12
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2026-01-12
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2026-01-12
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2026-01-12
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2026-01-12
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2026-01-12
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2026-01-12
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2022-06-16
JJI	Analyzer, Enzyme, For Clinical Use	Clinical Chemistry	Class 1	862.2500	2011-10-16
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2024-04-03
PUX	Test, Amphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3100	2018-12-19
PUY	Test, Barbiturate, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3150	2018-12-19
PVD	Test, Methamphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3610	2018-12-19
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2026-03-02
MKU	Enzyme Immunoassay, Nicotine And Nicotine Metabolites	Clinical Toxicology	Class 1	862.3220	2026-03-02
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2015-09-18
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2015-09-18
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2015-09-18
LHD	Device, Fertility Diagnostic, Proceptive	Unknown	Class U	N/A	2017-03-22
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2022-06-16
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2022-09-06
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2022-09-06
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2022-09-06
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2022-09-06
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2022-09-06
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2022-09-06
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2022-09-06
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2022-09-06
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2022-09-06
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2022-09-06
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2022-09-06
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2012-10-10
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2012-10-10
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2012-10-10
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2012-10-10
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2012-10-10
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2012-10-10
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2012-10-10
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2012-10-10
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2012-10-10
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2012-10-10
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2012-10-10
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2012-10-10
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2015-05-15
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2015-05-15
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2015-05-15
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2015-05-15
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2015-05-15
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2015-05-15
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2014-12-29
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2014-12-29
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2023-05-18
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2023-05-18
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2023-05-18
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2023-05-18
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2023-05-18
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2023-05-18
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2023-05-18
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2023-05-18
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2023-05-18
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2023-05-18
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2023-05-18
PVE	Test, Methadone, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3620	2018-12-19
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2015-08-19
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2015-08-19
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2015-08-19
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2015-08-19
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2015-08-19
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2015-08-19
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2015-08-19
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2015-08-19
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2015-08-19
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2022-06-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HEALGEN SCIENTIFIC LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K110182	Guangzhou Wondfo Biotech Co., Ltd.	CANNABINOIDS URINE TEST	2011-05-20
K121557	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST	2012-07-25
K920418	Instrumentation Laboratory CO	IL TEST CANNABINOID, 35282	1992-02-27
K924751	Solarcare Technologies Corp,Inc.	SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY	1992-12-11
K142044	Guangzhou Wondfo Biotech Co., Ltd.	CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE	2014-08-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0007-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0008-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0009-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0010-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009238284. Last updated year: 2026. Please use registration number 3009238284 when referencing this establishment in official correspondence.