| Urine Amphetamine Direct Ria Kit (i-125) | K913866 | FDA 510(k) | Class II | Active |
| Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set | K151203 | FDA 510(k) | Class II | Active |
| Urine Heroin/Morphine Direct Ria Kit (i-125) | K933572 | FDA 510(k) | Class II | Active |
| Immunalysis Tapentadol Urine HEIA | K203527 | FDA 510(k) | Class II | Active |
| Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | K161714 | FDA 510(k) | Class II | Active |
| SEFRIA PCP Oral Fluid Enzyme Immunoassay | K203489 | FDA 510(k) | U | Active |
| Immunalysis Amphetamine Elisa For Oral Fluids | K051579 | FDA 510(k) | Class II | Active |
| Thc Direct Ria Kit | K781048 | FDA 510(k) | Class II | Active |
| Phencyclidine Direct Blood Ria Kit | K800514 | FDA 510(k) | U | Active |
| Resubmission Of Urine Heroin/Morphine Kit [i-125] | K871698 | FDA 510(k) | Class II | Active |
| SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay | K203647 | FDA 510(k) | Class II | Active |
| Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | K153693 | FDA 510(k) | Class II | Active |
| Immunalysis Cocaine/Cocaine Metabolite Elisa For Oral Fluids | K051578 | FDA 510(k) | Class II | Active |
| Tetrahydrocannalbinol Direct Blood Kit | K791649 | FDA 510(k) | Class II | Active |
| SEFRIA™ Hydrocodone Oral Fluid | K252520 | FDA 510(k) | Class II | Active |
| Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | K151771 | FDA 510(k) | Class II | Active |
| Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set | K150925 | FDA 510(k) | Class II | Active |
| Luteinizing Hormone Direct Ria Kit 125/I | K811024 | FDA 510(k) | Class I | Active |
| Urine Cocaine Metabolite Direct Ria Kit (i-125) | K913867 | FDA 510(k) | Class II | Active |
| Progesterone Direct Ria Kit (125i) | K811907 | FDA 510(k) | Class I | Active |
| Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls | K143502 | FDA 510(k) | Class II | Active |
| Pcp Direct Ria Kit (i-125) | K913864 | FDA 510(k) | U | Active |
| Quantisal™ Oral Fluid Collection Device | K232898 | FDA 510(k) | Class II | Active |
| SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay | K203564 | FDA 510(k) | Class II | Active |
| Direct Estriol Ria Kit | K781546 | FDA 510(k) | Class I | Active |
| Urine Heroin/Morphine Direct Ria Kit (i-125) | K913863 | FDA 510(k) | Class II | Active |
| Immunalysis Methamphetamine Elisa For Oral Fluids | K051577 | FDA 510(k) | Class II | Active |
| Quantisal Oral Fluid Collection Device | K200801 | FDA 510(k) | Class II | Active |
| Quantisal™ II Oral Fluid Collection Device | K223781 | FDA 510(k) | Class II | Active |
| Follicle Stimulating Hormone Direct Ria | K811905 | FDA 510(k) | Class I | Active |
| Immunalysis Opiates Elisa For Oral Fluids | K051626 | FDA 510(k) | Class II | Active |
| Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay | K181135 | FDA 510(k) | U | Active |
| Urine Thc Direct Ria Kit (i-125) | K913865 | FDA 510(k) | Class II | Active |
| Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls | K150275 | FDA 510(k) | Class II | Active |
| Oral Thc-Cannabinoids Direct Ria Kit | K843534 | FDA 510(k) | Class II | Active |
| Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators | K161216 | FDA 510(k) | Class II | Active |
| Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set | K143500 | FDA 510(k) | Class II | Active |
| Resub. Urine Cocaine Meta. Direct Ria Kit [i-125] | K871549 | FDA 510(k) | Class II | Active |
| Immunalysis Ethyl Alcohol Enzyme Assay | K181553 | FDA 510(k) | Class II | Active |
| Immunalysis Cocaine Elisa For Hair | K050465 | FDA 510(k) | Class II | Active |
| Thc-Cannabinoids Direct Urine Ria Kit | K820903 | FDA 510(k) | Class II | Active |
| Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets | K151395 | FDA 510(k) | Class II | Active |
| Oral Thc-Cannabinoids Direct Ria Kit | K821965 | FDA 510(k) | Class II | Active |
| Immunalysis Tramadol Urine Enzyme Immunoassay | K141803 | FDA 510(k) | Class II | Active |
| Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | K152176 | FDA 510(k) | U | Active |
| Dhea-Sulfate Direct Ria Kit(125i) | K811906 | FDA 510(k) | Class I | Active |
| Immunalysis Oxycodone Enzyme Immunoassay | K131168 | FDA 510(k) | Class II | Active |