Healgen Scientific LLC
Houston, TX, US
HEALGEN SCIENTIFIC LLC appears in FDA device records in Houston, TX. FDA records list 27 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 27 510(k) clearances for Healgen Scientific LLC between 2012 and 2026. The busiest year on record is 2015, with 7. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 3 |
| 2015 | 7 |
| 2016 | 1 |
| 2017 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 4 |
| 2025 | 3 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260095 | Heal-Check Rapid COVID-19 Antigen Self-Test | QYT | Substantially Equivalent | |
| K253705 | Healgen® Accurate Oral Fluid Drug Test | DJC | Substantially Equivalent | |
| K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test | NFW | Substantially Equivalent | |
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | NGL | Substantially Equivalent | |
| K251800 | Healgen® URS Test Strips | JMT | Substantially Equivalent | |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) | DJG | Substantially Equivalent | |
| K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup | NGL | Substantially Equivalent | |
| 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 | |
| K232377 | Healgen Rapid COVID-19 Antigen Test | QVF | Substantially Equivalent | |
| K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | NGL | Substantially Equivalent | |
| K231045 | Healgen URS Test Strips | LJX | Substantially Equivalent | |
| K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT | LDJ | Substantially Equivalent | |
| K212623 | Healgen Strep A Rapid Test Strip (Throat Swab) | GTY | Substantially Equivalent | |
| K163704 | Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card | JXM | Substantially Equivalent | |
| K153597 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | JXM | Substantially Equivalent | |
| 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 | |
| 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 | |
| K151642 | Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | JXM | Substantially Equivalent | |
| K150356 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | JXM | Substantially Equivalent | |
| 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 | |
| K150096 | Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) | LAF | Substantially Equivalent | |
| K143187 | Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) | DJG | Substantially Equivalent | |
| K142280 | Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) | DJG | Substantially Equivalent | |
| K141647 | HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD) | DIO | Substantially Equivalent | |
| K140546 | HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST | LDJ | Substantially Equivalent | |
| K123703 | HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE) | LCX | Substantially Equivalent | |
| K111999 | HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL | JIO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009238284 | 3009238284 | HEALGEN SCIENTIFIC LLC | 3818 Fuqua St, Houston, TX 77047 US | 2026 | and 67 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- JJIAnalyzer, Enzyme, For Clinical Use
- GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- GTYAntigens, All Groups, Streptococcus Spp.
- KQOAutomated Urinalysis System
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- JIOBlood, Occult, Colorimetric, In Urine
- JJHClinical Sample Concentrator
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- NNIContainer, Specimen, Non-Sterile
- OSLControl, Fecal Occult Blood
- LHDDevice, Fertility Diagnostic, Proceptive
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- MKUEnzyme Immunoassay, Nicotine And Nicotine Metabolites
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- JXNEnzyme Immunoassay, Propoxyphene
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- LAFGas Chromatography, Methamphetamine
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- MKAKit, Direct Antigen, Negative Control
- MJZKit, Direct Antigen, Positive Control
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- JQXNephelometer, For Clinical Use
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- LNWPaper, Obstetric Ph
- LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
- KHEReagent, Occult Blood
- JRERefractometer For Clinical Use
- MRSTest System, Nicotine, Cotinine, Metabolites
- PUXTest, Amphetamine, Employment And Insurance Testing, Exempt
- NFTTest, Amphetamine, Over The Counter
- PUYTest, Barbiturate, Employment And Insurance Testing, Exempt
- PTHTest, Barbiturate, Over The Counter
- PUZTest, Benzodiazepine, Employment And Insurance Testing, Exempt
- NFVTest, Benzodiazepine, Over The Counter
- NFWTest, Cannabinoid, Over The Counter
- PVATest, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt
- NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
- PVBTest, Codeine, Employment And Insurance Testing, Exempt
- NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter
- NGETest, Luteinizing Hormone (Lh), Over The Counter
- PTGTest, Methadone, Over The Counter
- PVDTest, Methamphetamine, Employment And Insurance Testing, Exempt
- NGGTest, Methamphetamine, Over The Counter
- NGLTest, Opiates, Over The Counter
- NGMTest, Phencyclidine (Pcp), Over The Counter
- LJXTest, Urine Leukocyte
- DJCThin Layer Chromatography, Methamphetamine
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3303-2024 | 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 and comparing with the corresponding blocks on a color chart. The Healgen Series Reagent Strips for Urinalysis provides tests for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Ascorbic Acid and Leukocytes in Urine. | 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, their evaluation, and/or other conditions associated with elevated protein levels in urine and subsequently a delay in patient treatment. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain