Houston, TX, US · 13 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| NGL | Test, Opiates, Over The Counter | Class II | Clinical Toxicology | 4 | 2025-12-23 |
| QYT | Over-The-Counter Covid-19 Antigen Test | Class II | Microbiology | 1 | 2026-04-13 |
| DJC | Thin Layer Chromatography, Methamphetamine | Class II | Clinical Toxicology | 1 | 2026-03-16 |
| NFW | Test, Cannabinoid, Over The Counter | Class II | Clinical Toxicology | 1 | 2026-02-12 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Class I | Clinical Chemistry | 1 | 2025-12-23 |
| DJG | Enzyme Immunoassay, Opiates | Class II | Clinical Toxicology | 1 | 2025-08-15 |
| QVF | Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | Class II | Microbiology | 1 | 2024-04-19 |
| LJX | Test, Urine Leukocyte | Class I | Hematology | 1 | 2023-06-16 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Class II | Clinical Toxicology | 1 | 2023-03-17 |
| GTY | Antigens, All Groups, Streptococcus Spp. | Class I | Microbiology | 1 | 2022-03-16 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-08-22 | Class II | Ongoing | Z-3303-2024 | Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is emp… | — | The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products have shown reduced sensitivity, or potential fals… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-04-13 | K260095 | Heal-Check Rapid COVID-19 Antigen Self-Test | QYT | Class II | Microbiology |
| 2026-03-16 | K253705 | Healgen® Accurate Oral Fluid Drug Test | DJC | Class II | Clinical Toxicology |
| 2026-02-12 | K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test | NFW | Class II | Clinical Toxicology |
| 2025-12-23 | K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | NGL | Class II | Clinical Toxicology |
| 2025-12-23 | K251800 | Healgen® URS Test Strips | JMT | Class I | Clinical Chemistry |
| 2025-08-15 | K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) | DJG | Class II | Clinical Toxicology |
| 2024-12-17 | K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup | NGL | Class II | Clinical Toxicology |
| 2024-05-13 | 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 | Class II | Clinical Toxicology |
| 2024-04-19 | K232377 | Healgen Rapid COVID-19 Antigen Test | QVF | Class II | Microbiology |
| 2024-04-12 | K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | NGL | Class II | Clinical Toxicology |
| 2023-06-16 | K231045 | Healgen URS Test Strips | LJX | Class I | Hematology |
| 2023-03-17 | K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT | LDJ | Class II | Clinical Toxicology |
| 2022-03-16 | K212623 | Healgen Strep A Rapid Test Strip (Throat Swab) | GTY | Class I | Microbiology |