| Heal-Check Rapid COVID-19 Antigen Self-Test (K260095) | Healgen Scientific,, LLC | 2026-04-13 |
| Healgen® Accurate Oral Fluid Drug Test (K253705) | Healgen Scientific,, LLC | 2026-03-16 |
| Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test (K252523) | Healgen Scientific,, LLC | 2026-02-12 |
| Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card (K253567) | Healgen Scientific,, LLC | 2025-12-23 |
| Healgen® URS Test Strips (K251800) | Healgen Scientific,, LLC | 2025-12-23 |
| Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) (K251972) | Healgen Scientific,, LLC | 2025-08-15 |
| Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup (K243365) | Healgen Scientific,, LLC | 2024-12-17 |
| 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) (K240949) | Healgen Scientific,, LLC | 2024-05-13 |
| Healgen Rapid COVID-19 Antigen Test (K232377) | Healgen Scientific,, LLC | 2024-04-19 |
| Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card (K240686) | Healgen Scientific,, LLC | 2024-04-12 |
| Healgen URS Test Strips (K231045) | Healgen Scientific,, LLC | 2023-06-16 |
| Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT (K223162) | Healgen Scientific,, LLC | 2023-03-17 |
| Healgen Strep A Rapid Test Strip (Throat Swab) (K212623) | Healgen Scientific,, LLC | 2022-03-16 |
| Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card (K163704) | Healgen Scientific,, LLC | 2017-08-02 |
| Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (K153597) | Healgen Scientific,, LLC | 2016-05-23 |
| Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card) (K152269) | Healgen Scientific,, LLC | 2015-09-09 |
| 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) (K151348) | Healgen Scientific,, LLC | 2015-08-18 |
| Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (K151642) | Healgen Scientific,, LLC | 2015-08-13 |
| Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (K150356) | Healgen Scientific,, LLC | 2015-05-13 |
| Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card) (K150791) | Healgen Scientific,, LLC | 2015-04-24 |
| Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) (K150096) | Healgen Scientific,, LLC | 2015-03-04 |
| Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) (K143187) | Healgen Scientific,, LLC | 2015-01-27 |
| Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) (K142280) | Healgen Scientific,, LLC | 2014-10-16 |
| HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD) (K141647) | Healgen Scientific,, LLC | 2014-07-17 |
| HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST (K140546) | Healgen Scientific,, LLC | 2014-06-06 |
| HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE) (K123703) | Healgen Scientific,, LLC | 2013-04-10 |
| HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL (K111999) | Healgen Scientific,, LLC | 2012-04-17 |