| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | Class 1 | Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer, Healgen Scientific LLC Healgen 500 Urine Analyzer, Healgen Scientific LLC Healgen Reagent Strip for Urinalysis (Manual – Qualitative), Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} | 2014 | 10 |
| Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | Class 2 | | 2020 | 2 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Class 1 | Healgen | 2010 | 16 |
| Analyzer, Enzyme, For Clinical Use | Class 1 | healgen | 2010 | 3 |
| Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | Class 1 | Healgen Scientific LLC. Rapid Check RSV Antigen Test Cassette, Healgen Scientific LLC Rapid Check RSV Antigen Test (Nasopharyngeal swabs) | 2022 | 4 |
| Antigens, All Groups, Streptococcus Spp. | Class 1 | Healgen Scientific LLC Strep A Rapid Test Strip (Throat Swab), Healgen Scientific LLC Strep A Antigen Test | 2022 | 6 |
| Automated Urinalysis System | Class 1 | Healgen, Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer, Healgen Scientific LLC Healgen 500 Urine Analyzer, Healgen Scientific LLC Healgen Reagent Strip for Urinalysis (Manual – Qualitative), Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} | 2010 | 16 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | Class 1 | Life2O Full Panel Liver Function Urinalysis Test, Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer, Healgen Scientific LLC Healgen 500 Urine Analyzer, Healgen Scientific LLC Healgen Reagent Strip for Urinalysis (Manual – Qualitative), Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} | 2014 | 12 |
| Biuret (Colorimetric), Total Protein | Class 2 | healgen | 2010 | 3 |
| Blood, Occult, Colorimetric, In Urine | Class 2 | Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer, Healgen Scientific LLC Healgen 500 Urine Analyzer, Healgen Scientific LLC Healgen Reagent Strip for Urinalysis (Manual – Qualitative), Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} | 2014 | 5 |
| Clinical Sample Concentrator | Class 1 | | 2021 | 27 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | Class 1 | Healgen | 2010 | 13 |
| Colorimetric Method, Triglycerides | Class 1 | healgen | 2010 | 5 |
| Container, Specimen, Sterile | Class 1 | | 2019 | 79 |
| Control, Fecal Occult Blood | Class 2 | External Controls → Second Generation FOB Rapid Test Cassette | 2026 | 3 |
| Coronavirus Antigen Detection Test System. | Class N | | 2020 | 12 |
| Covid-19 Multi-Analyte Antigen Device | Class N | Healgen COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) | 2024 | 7 |
| Densitometeric, Protein Fractionation | Class 1 | healgen | 2010 | 1 |
| Device, Fertility Diagnostic, Proceptive | Class U | | 2017 | 3 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Class 1 | Healgen Scientific LLC, URcheck URS Test Strip, Healgen Scientific LLC URcheck UTI Test Strip, Easy Healthcare Corporation easy@Home Urinary Tract Infection Test, Healgen Scientific LLC, Healgen URS Test Strip, Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer and 4 more | 2014 | 14 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | Class 1 | Life2O Full Panel Liver Function Urinalysis Test, Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer, Healgen Scientific LLC Healgen 500 Urine Analyzer, Healgen Scientific LLC Healgen Reagent Strip for Urinalysis (Manual – Qualitative), Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} | 2014 | 11 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | Class 1 | Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer, Healgen Scientific LLC Healgen 500 Urine Analyzer, Healgen Scientific LLC Healgen Reagent Strip for Urinalysis (Manual – Qualitative), Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} | 2014 | 16 |
| Enzymatic (Glutathione Reductase), Glutathione | Class 1 | healgen | 2010 | 2 |
| Enzymatic Esterase–Oxidase, Cholesterol | Class 1 | healgen | 2010 | 9 |
| Enzyme Immunoassay, Amphetamine | Class 2 | Healgen Scientific LLC Healgen Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Multi-Drug Urine Test Dip Card, Healgen Amphetamine Test Dip Card, Healgen Amphetamine Test Strip, Healgen Amphetamine Test Cup, Healgen Amphetamine Test Cassette and 5 more | 2015 | 16 |
| Enzyme Immunoassay, Barbiturate | Class 2 | Healgen Scientific LLC Healgen Secobarbital Test Dip Card, Healgen Scientific LLC Healgen Secobarbital Test Cup, Healgen Scientific LLC Healgen Methadone Test Cup, Healgen Scientific LLC Healgen Buprenorphine Test Strip, Healgen Scientific LLC Healgen Methadone Test Cassette, Healgen Scientific LLC Healgen Buprenorphine Test Cup and 9 more | 2015 | 12 |
| Enzyme Immunoassay, Benzodiazepine | Class 2 | Healgen Scientific LLC Healgen Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Multi-Drug Urine Test Dip Card, Healgen Morphine Test Cassette, SCI Medical Group U-Check Opioid Home Drug (Test Strip), Healgen Oxazepam Test Strip, Healgen Oxazepam Test Cassette and 11 more | 2015 | 13 |
| Enzyme Immunoassay, Cannabinoids | Class 2 | Healgen Scientific LLC Healgen Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Multi-Drug Urine Test Dip Card, Healgen Scientific LLC Accurate Urine DOA Rapid Test Dipcard | 2015 | 18 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Class 2 | Healgen Scientific LLC Healgen Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Multi-Drug Urine Test Dip Card, Healgen Scientific LLC Accurate Urine DOA Rapid Test Dipcard | 2015 | 16 |
| Enzyme Immunoassay, Methadone | Class 2 | Healgen Scientific LLC Healgen Secobarbital Test Dip Card, Healgen Scientific LLC Healgen Secobarbital Test Cup, Healgen Scientific LLC Healgen Methadone Test Cup, Healgen Scientific LLC Healgen Buprenorphine Test Strip, Healgen Scientific LLC Healgen Methadone Test Cassette, Healgen Scientific LLC Healgen Buprenorphine Test Cup and 9 more | 2015 | 11 |
| Enzyme Immunoassay, Nicotine And Nicotine Metabolites | Class 1 | | 2023 | 2 |
| Enzyme Immunoassay, Opiates | Class 2 | Healgen Scientific LLC Healgen Secobarbital Test Dip Card, Healgen Scientific LLC Healgen Secobarbital Test Cup, Healgen Scientific LLC Healgen Methadone Test Cup, Healgen Scientific LLC Healgen Buprenorphine Test Strip, Healgen Scientific LLC Healgen Methadone Test Cassette, Healgen Scientific LLC Healgen Buprenorphine Test Cup and 31 more | 2015 | 17 |
| Enzyme Immunoassay, Phencyclidine | Class U | Healgen Scientific LLC Accurate Urine DOA Rapid Test Dipcard, Healgen Scientific LLC Healgen Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Multi-Drug Urine Test Dip Card, HEALGEN SCIENTIFIC LLC Healgen Phencyclidine Test Dip Card, HEALGEN SCIENTIFIC LLC Healgen Phencyclidine Test Strip, HEALGEN SCIENTIFIC LLC Healgen Phencyclidine Test Cup and 5 more | 2015 | 16 |
| Enzyme Immunoassay, Propoxyphene | Class 2 | | 2015 | 10 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class 1 | Healgen | 2010 | 72 |
| Fluorometer | Class 1 | healgen | 2010 | 8 |
| Gas Chromatography, Methamphetamine | Class 2 | Healgen Scientific LLC Healgen Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Multi-Drug Urine Test Dip Card, Healgen Scientific LLC Accurate Urine DOA Rapid Test Dipcard, HEALGEN SCIENTIFIC LLC Healgen Phencyclidine Test Dip Card, HEALGEN SCIENTIFIC LLC Healgen Phencyclidine Test Strip, HEALGEN SCIENTIFIC LLC Healgen Phencyclidine Test Cup and 5 more | 2015 | 10 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | Class 1 | Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer, Healgen Scientific LLC Healgen 500 Urine Analyzer, Healgen Scientific LLC Healgen Reagent Strip for Urinalysis (Manual – Qualitative), Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} | 2014 | 14 |
| Kinetic Method, Gamma-Glutamyl Transpeptidase | Class 1 | healgen | 2010 | 1 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | Class 2 | Healgen hCG One Step Pregnancy Test strip, Healgen hCG One Step Pregnancy Test Cassette | 2011 | 30 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | Class 2 | Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer, Healgen Scientific LLC Healgen 500 Urine Analyzer, Healgen Scientific LLC Healgen Reagent Strip for Urinalysis (Manual – Qualitative), Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} | 2014 | 5 |
| Multi-Analyte Respiratory Virus Antigen Detection Test | Class 2 | Healgen Scientific LLC, Healgen Rapid Check COVID-19/Flu A&B Antigen Test, Healgen Scientific LLC, Healgen Rapid Check COVID-19/Flu A&B Antigen Test PRO | 2024 | 4 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | Class 1 | healgen | 2010 | 3 |
| Nephelometer | Class 1 | healgen | 2010 | 4 |
| Nephelometer, For Clinical Use | Class 1 | healgen | 2010 | 2 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | Class 1 | Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer, Healgen Scientific LLC Healgen 500 Urine Analyzer, Healgen Scientific LLC Healgen Reagent Strip for Urinalysis (Manual – Qualitative), Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} | 2014 | 17 |
| Olive Oil Emulsion (Turbidimetric), Lipase | Class 1 | healgen | 2010 | 1 |
| Over-The-Counter Covid-19 Antigen Test | Class 2 | | 2026 | 5 |
| Paper, Obstetric Ph | Class 1 | | 2021 | 13 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | Class 2 | | 2015 | 9 |
| Reagent, Coronavirus Serological | Class N | | 2020 | 12 |
| Reagent, Occult Blood | Class 2 | | 2011 | 5 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | Class N | | 2020 | 5 |
| Real Time Nucleic Acid Amplification System | Class 2 | | 2020 | 15 |
| Refractometer For Clinical Use | Class 1 | Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer, Healgen Scientific LLC Healgen 500 Urine Analyzer, Healgen Scientific LLC Healgen Reagent Strip for Urinalysis (Manual – Qualitative), Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} | 2014 | 8 |
| Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | Class 2 | | 2024 | 3 |
| Test System, Nicotine, Cotinine, Metabolites | Class 1 | | 2019 | 11 |
| Test, Amphetamine, Employment And Insurance Testing, Exempt | Class 2 | | 2019 | 11 |
| Test, Amphetamine, Over The Counter | Class 2 | Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Urine Drug Screen Dip Card;, Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Accurate Multi-Drug Urine Screening Cup | 2019 | 16 |
| Test, Barbiturate, Employment And Insurance Testing, Exempt | Class 2 | | 2019 | 11 |
| Test, Barbiturate, Over The Counter | Class 2 | Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Urine Drug Screen Dip Card;, Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Accurate Multi-Drug Urine Screening Cup | 2019 | 16 |
| Test, Benzodiazepine, Employment And Insurance Testing, Exempt | Class 2 | | 2019 | 11 |
| Test, Benzodiazepine, Over The Counter | Class 2 | Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Urine Drug Screen Dip Card;, Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Accurate Multi-Drug Urine Screening Cup | 2019 | 16 |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | Class 2 | | 2019 | 12 |
| Test, Cannabinoid, Over The Counter | Class 2 | Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Urine Drug Screen Dip Card;, Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Accurate Multi-Drug Urine Screening Cup | 2019 | 16 |
| Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt | Class 2 | | 2019 | 12 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | Class 2 | Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Urine Drug Screen Dip Card;, Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Accurate Multi-Drug Urine Screening Cup | 2019 | 16 |
| Test, Codeine, Employment And Insurance Testing, Exempt | Class 2 | | 2019 | 4 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Class 1 | | 2025 | 30 |
| Test, Luteinizing Hormone (Lh), Over The Counter | Class 1 | Healgen Scientific LLC., LH Luteinizing Hormone Test | 2010 | 38 |
| Test, Methadone, Employment And Insurance Testing, Exempt | Class 2 | | 2019 | 11 |
| Test, Methadone, Over The Counter | Class 2 | Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Urine Drug Screen Dip Card;, Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Accurate Multi-Drug Urine Screening Cup | 2019 | 17 |
| Test, Methamphetamine, Employment And Insurance Testing, Exempt | Class 2 | | 2019 | 13 |
| Test, Methamphetamine, Over The Counter | Class 2 | Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Urine Drug Screen Dip Card;, Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Accurate Multi-Drug Urine Screening Cup | 2019 | 16 |
| Test, Methaqualone, Employment And Insurance Testing, Exempt | Class 2 | | 2019 | 6 |
| Test, Morphine, Employment And Insurance Testing, Exempt | Class 2 | | 2019 | 8 |
| Test, Opiates, Employment And Insurance Testing, Exempt | Class 2 | | 2019 | 12 |
| Test, Opiates, Over The Counter | Class 2 | Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Urine Drug Screen Dip Card;, Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Accurate Multi-Drug Urine Screening Cup, Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine), Healgen® Accurate Rapid Fentanyl Test Strip (Urine) and 4 more | 2019 | 18 |
| Test, Phencyclidine (Pcp), Over The Counter | Class U | Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Urine Drug Screen Dip Card;, Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Accurate Multi-Drug Urine Screening Cup | 2019 | 12 |
| Test, Propoxyphene, Employment And Insurance Testing, Exempt | Class 2 | | 2019 | 7 |
| Test, Propoxyphene, Over The Counter | Class 2 | Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Urine Drug Screen Dip Card;, Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Accurate Multi-Drug Urine Screening Cup | 2019 | 16 |
| Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt | Class 2 | | 2019 | 7 |
| Test, Tricyclic Antidepressants, Over The Counter | Class 2 | Healgen Accurate Home Urine Drug Test Dip Card, Healgen Accurate Urine Drug Screen Dip Card;, Healgen Scientific LLC Healgen Accurate Home Multi-Drug Urine Test Cup, Healgen Scientific LLC Healgen Accurate Multi-Drug Urine Screening Cup | 2019 | 16 |
| Test, Urine Leukocyte | Class 1 | Healgen Scientific LLC, URcheck URS Test Strip, Healgen Scientific LLC URcheck UTI Test Strip, Easy Healthcare Corporation easy@Home Urinary Tract Infection Test, Healgen Scientific LLC, Healgen URS Test Strip, Healgen Scientific LLC Healgen 800 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, Healgen Scientific LLC Healgen 800 Urine Analyzer and 4 more | 2014 | 16 |
| Thin Layer Chromatography, Methamphetamine | Class 2 | | 2026 | 12 |
| Turbidimetric Method, Lipoproteins | Class 1 | healgen | 2010 | 1 |