| Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | K223093 | FDA 510(k) | Class II | Active |
| Quanta Lite B2gpi Igg | K970551 | FDA 510(k) | Class II | Active |
| Quanta Lite H. Pylori Igg Elisa | K982790 | FDA 510(k) | Class I | Active |
| Quanta Lite Iga Aca (hrp) | K953366 | FDA 510(k) | Class II | Active |
| Quanta Lite Iga Gliadin Elisa | K964986 | FDA 510(k) | Class II | Active |
| Quanta Lite F-Actin Iga Elisa | K072967 | FDA 510(k) | Class II | Active |
| Quanta Lite Lyme Igm Elisa | K984234 | FDA 510(k) | Class II | Active |
| Quanta Lite Rf Igm | K971614 | FDA 510(k) | Class II | Active |
| Quanta Flash Ss-B, Quanta Flash Ss-B Calibrators, And Quanta Flash Ss-B Controls | K141210 | FDA 510(k) | Class II | Active |
| QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents | K190088 | FDA 510(k) | Class II | Active |
| Quanta Lite Ena 6 Elisa | K961913 | FDA 510(k) | Class II | Active |
| Quanta Lite H-Ttg Screen | K073145 | FDA 510(k) | Class II | Active |
| Quanta Lite Sm Elisa | K922831 | FDA 510(k) | Class II | Active |
| QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls | K163525 | FDA 510(k) | Class II | Active |
| Quanta Lite B2 Gpi Iga | K973006 | FDA 510(k) | Class II | Active |
| Quanta Lite(tm) Iga Aca | K922351 | FDA 510(k) | Class II | Active |
| Quanta Lite Rna Pol Iii Elisa | K070066 | FDA 510(k) | Class II | Active |
| Nova Lite Tm Thyroid | K904224 | FDA 510(k) | Class II | Active |
| Quanta Lite Ssdna | K954380 | FDA 510(k) | Class II | Active |
| Quanta Lite(tm) Aca | K911680 | FDA 510(k) | Class II | Active |
| Quanta Flash Ro60, Quanta Flash Ro60 Calibrators, Quanta Flash Ro60 Controls | K141328 | FDA 510(k) | Class II | Active |
| Quanta Lite H.pylori Iga Elisa | K024334 | FDA 510(k) | Class I | Active |
| QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls | K152013 | FDA 510(k) | Class II | Active |
| Nova Lite(tm) Ana Plus | K881339 | FDA 510(k) | Class II | Active |
| Quanta Lite Lyme Igg Elisa | K984222 | FDA 510(k) | Class II | Active |
| Quanta Lite Aca Igm (hrp) | K946385 | FDA 510(k) | Class II | Active |
| Quanta Lite Chromatin Elisa | K982603 | FDA 510(k) | Class II | Active |
| Quanta Lite H-Ttg (human Tissue Transglutaminase) Igg Elisa | K011570 | FDA 510(k) | Class II | Active |
| Quanta Lite Aca Screen | K923320 | FDA 510(k) | Class II | Active |
| Quanta Plex Celiac Igg Profile | K072632 | FDA 510(k) | Class II | Active |
| Quanta Lite Tm Dsdna | K903898 | FDA 510(k) | Class II | Active |
| QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls | K163538 | FDA 510(k) | Class II | Active |
| Nova Lite Anca | K961340 | FDA 510(k) | Class II | Active |
| Quanta Lite Gpa (gastric Parietal Cell Antibody) Elisa | K010558 | FDA 510(k) | Class II | Active |
| Quanta Flash Centromere | K123880 | FDA 510(k) | Class II | Active |
| Nova Lite(tm) Ana Mk | K901595 | FDA 510(k) | Class II | Active |
| Quanta Lite Sla (soluble Liver Antigen) Elisa | K021482 | FDA 510(k) | Class II | Active |
| Quanta Flash Ena7 | K122923 | FDA 510(k) | Class II | Active |
| Quanta Lite Pbc Screen Igg/Iga Elisa | K061842 | FDA 510(k) | Class II | Active |
| Nova Gel(tm) T Ss-A/Ss-B | K896460 | FDA 510(k) | Class II | Active |
| Quanta Lite Intrinsic Factor Elisa | K061841 | FDA 510(k) | Class II | Active |
| Quanta Lite Rubeola (measles) Igg | K971620 | FDA 510(k) | Class I | Active |
| QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer | K170993 | FDA 510(k) | Class II | Active |
| Quanta Lite Aps/Pt Igg And Igm Elisa | K090755 | FDA 510(k) | Class II | Active |
| NOVA Lite DAPI ANA Kit | K150155 | FDA 510(k) | Class II | Active |
| QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls | K152635 | FDA 510(k) | Class II | Active |
| Nova Lite(tm) Ana Ksl | K901596 | FDA 510(k) | Class II | Active |
| Nova Gel(tm) T Sm/Rnp | K896459 | FDA 510(k) | Class II | Active |
| Quanta Flash ¿2gp1-Domain1; Controls, Hemosil Acustar Anti-¿2gpi Domain1; Controls. | K141274 | FDA 510(k) | Class II | Active |
| Quanta Lite Lyme B. Burgdorferi Igg/Igm Elisa Kit | K994004 | FDA 510(k) | Class II | Active |