Healgen Scientific,, LLC
Dispositifs autorisés FDA 510(k) et PMA — 15 produits
Publicité
Nombre total de dispositifs15
Catégories0
Dernière décision de la FDA
| Type | Numéro | Nom du dispositif | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K260095 | Heal-Check Rapid COVID-19 Antigen Self-Test | QYT | 2026-04-13 | Voir |
| 510(k) | K253705 | Healgen® Accurate Oral Fluid Drug Test | DJC | 2026-03-16 | Voir |
| 510(k) | K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test | NFW | 2026-02-12 | Voir |
| 510(k) | K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | NGL | 2025-12-23 | Voir |
| 510(k) | K251800 | Healgen® URS Test Strips | JMT | 2025-12-23 | Voir |
| 510(k) | K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) | DJG | 2025-08-15 | Voir |
| 510(k) | K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup | NGL | 2024-12-17 | Voir |
| 510(k) | 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 | 2024-05-13 | Voir |
| 510(k) | K232377 | Healgen Rapid COVID-19 Antigen Test | QVF | 2024-04-19 | Voir |
| 510(k) | K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | NGL | 2024-04-12 | Voir |
| 510(k) | K231045 | Healgen URS Test Strips | LJX | 2023-06-16 | Voir |
| 510(k) | K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT | LDJ | 2023-03-17 | Voir |
| 510(k) | K212623 | Healgen Strep A Rapid Test Strip (Throat Swab) | GTY | 2022-03-16 | Voir |
| 510(k) | K163704 | Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card | JXM | 2017-08-02 | Voir |
| 510(k) | K153597 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | JXM | 2016-05-23 | Voir |
Aucun dispositif correspondant.