| Elecsys Probnp Ii, Precicontrol Cardiac Ii, Probnp Ii Calset | K072437 | FDA 510(k) | Class II | Active |
| Roche Elecsys Anti-Tg | K053426 | FDA 510(k) | Class II | Active |
| Elecsys Anti-Tpo Calcheck | K001014 | FDA 510(k) | Class I | Active |
| Elecsys Rubella Igg Calcheck | K090311 | FDA 510(k) | Class I | Active |
| Roche Diagnostics Cobas Integra Albumin Gen. 2 | K033009 | FDA 510(k) | Class II | Active |
| Elecsys HSV-2 IgG (08948887160) | K220924 | FDA 510(k) | Class II | Active |
| Elecsys Syphilis | K160910 | FDA 510(k) | Class II | Active |
| Roche Elecsys Troponin T Stat (short Turnaround Time) | K051752 | FDA 510(k) | Class II | Active |
| Elecsys Ige Calcheck 5 | K102269 | FDA 510(k) | Class I | Active |
| Accu-Chek Aviva Test Strips | K060620 | FDA 510(k) | Class II | Active |
| Modification To Reflotron Amylase, Cat. 1200658 | K011145 | FDA 510(k) | Class II | Active |
| Elecsys Hcg Stat Claset Ii | K003941 | FDA 510(k) | Class II | Active |
| Modification To Elecsys Fsh Ii Calset | K012399 | FDA 510(k) | Class II | Active |
| Chemstrip 5 Ob, Chemstrip 7 And Chemstrip 10 Md Test Strips | K032437 | FDA 510(k) | Class II | Active |
| Tina-Quant Soluble Transferrin Receptor Test System, Hitachi Catalog # 2148315; Integra Catalog # 2148323 | K003064 | FDA 510(k) | Class II | Active |
| Elecsys Anti-TSHR | K193313 | FDA 510(k) | Class II | Active |
| Ise Indirect Na, K, C1 For Gen 2 | K140373 | FDA 510(k) | Class II | Active |
| Ceruloplasmin, Model 2055953 | K062114 | FDA 510(k) | Class II | Active |
| Tina-Quant Hemoglobin A1c Gen.2 Test | K052464 | FDA 510(k) | Class II | Active |
| Elecsys Anti-Tpo Calset | K103171 | FDA 510(k) | Class II | Active |
| Online Phenobarbital, Model 03016757190 & 03510620 | K071644 | FDA 510(k) | Class II | Active |
| Elecsys sFlt-1 and Elecsys PlGF | K241453 | FDA 510(k) | Class II | Active |
| Coaguchek Xs Pt Controls | K063823 | FDA 510(k) | Class II | Active |
| Elecsys CYFRA 21-1 CalCheck 5 | K162173 | FDA 510(k) | Class I | Active |
| Oral Fluid Phencyclidine | K093989 | FDA 510(k) | U | Active |
| Elecsys Toxo Igg Calcheck | K083655 | FDA 510(k) | Class I | Active |
| Calcium Gen. 2 | K113521 | FDA 510(k) | Class II | Active |
| Act Test Catridges For Coaguchek Pro System, Act Controls For Coaguchek Pro System | K992851 | FDA 510(k) | Class II | Active |
| Elecsys Testosterone Ii Immunoassay | K093421 | FDA 510(k) | Class I | Active |
| Cobas Integra Carbon Dioxide Assay | K031879 | FDA 510(k) | Class II | Active |
| Elecsys AMH | K203757 | FDA 510(k) | Class II | Active |
| Elecsys Hcg Stat Calcheck 5 | K093700 | FDA 510(k) | Class I | Active |
| Abuscreen Online Opiates 300 / 2000 | K013482 | FDA 510(k) | Class II | Active |
| Tina-Quant Apolipoprotein B Ver.2 | K013206 | FDA 510(k)FDA UDI | Class II | Active |
| Elecsys FT4 III | K181233 | FDA 510(k) | Class II | Active |
| Ontrak Testcup 501, Model 3016633 | K001421 | FDA 510(k) | Class II | Active |
| Ontrak Testcup Pro-5, Model 1986678 | K001356 | FDA 510(k) | Class II | Active |
| Tina-Quant Hba1c Gen.2 | K110313 | FDA 510(k) | Class II | Active |
| Roche Diagnostics Calibrator For Automated Systems, Roche Diagnostics Calibrator Calibrator For Automated System | K101456 | FDA 510(k) | Class II | Active |
| Ontrak Testcup-Er M2k | K990418 | FDA 510(k) | Class II | Active |
| Elecsys C-Peptide Calcheck 5 | K100810 | FDA 510(k) | Class I | Active |
| Elecsys Insulin Calset | K001906 | FDA 510(k) | Class II | Active |
| Elecsys T-Uptake Calset | K143342 | FDA 510(k) | Class II | Active |
| Accu-Chek Advantage System | K032552 | FDA 510(k) | Class II | Active |
| Online Tdm Procainamide | K060773 | FDA 510(k) | Class II | Active |
| Online Tdm Tobramycin | K060853 | FDA 510(k) | Class II | Active |
| Elecys Cmv Igm Immunoassay; Elecys Precicontrol Cmv Igm | K142133 | FDA 510(k) | Class II | Active |
| Elecsys Estradiol Iii Calcheck 5 | K142127 | FDA 510(k) | Class I | Active |
| Elecsys Anti-Tg Calcheck | K020369 | FDA 510(k) | Class I | Active |
| Elecsys Estradiol III Calcheck | K143284 | FDA 510(k) | Class I | Active |