| Nova Gel (tm) Scl-70 | K880897 | FDA 510(k) | Class II | Active |
| Quanta Lite Actin (anti-Smooth Muscle) Elisa | K021648 | FDA 510(k) | Class II | Active |
| Quanta Lite Cmv Igg Elisa | K971335 | FDA 510(k) | Class II | Active |
| Quanta Plex Ena Profile 5 | K030681 | FDA 510(k) | Class II | Active |
| Quanta Lite Centromere (cenp-A & Cenp-B) Elisa | K003959 | FDA 510(k) | Class II | Active |
| Quanta Flash H-Ttg Iga | K094060 | FDA 510(k) | Class II | Active |
| Quanta Lite Pr3 Igg (serine Protease) Test Kit | K981328 | FDA 510(k) | Class II | Active |
| QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 | K143754 | FDA 510(k) | Class II | Active |
| Quanta Lite Ena 5 Elisa Kit | K943076 | FDA 510(k) | Class II | Active |
| Quanta Lite B2gpi Igm | K973014 | FDA 510(k) | Class II | Active |
| Nova Gel(tm) Ss-A/Ss-B | K880896 | FDA 510(k) | Class II | Active |
| Nova Lite(tm) Sa | K881341 | FDA 510(k) | Class II | Active |
| Quanta Lite Ribosome P Elisa | K981237 | FDA 510(k)FDA UDI | Class II | Active |
| Quanta Lite(tm) Scl-70 Elisa | K924898 | FDA 510(k) | Class II | Active |
| Quanta Lite Ttg (tissue Transglutaminase) Elisa | K982366 | FDA 510(k) | Class II | Active |
| Quanta Lite Gliadin Igg Ii | K052142 | FDA 510(k) | Class II | Active |
| QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls | K152875 | FDA 510(k) | Class II | Active |
| Quanta Lite Rf Igg Elisa | K983083 | FDA 510(k) | Class II | Active |
| Nova Lite(tm) Autoantibody Controls | K881340 | FDA 510(k) | Class II | Active |
| Quanta Lite Ana Elisa | K991657 | FDA 510(k) | Class II | Active |
| Quanta Lite Mpo | K955022 | FDA 510(k) | Class II | Active |
| Quanta Flash Acl Lga, Quanta Flash B2gp1 Iga | K120817 | FDA 510(k) | Class II | Active |
| Quanta Lite Gbm Elisa | K984336 | FDA 510(k) | Class II | Active |
| Quanta Lite Ena Elisa | K922829 | FDA 510(k) | Class II | Active |
| QUANTA Flash Calprotectin and Fecal Extraction Device | K180971 | FDA 510(k) | Class II | Active |
| Pelicalss Human Igg Subclass Nephlometric Array Kit | K982023 | FDA 510(k) | Class I | Active |
| NOVA View Automated Fluorescense Microscope | DEN140039 | FDA 510(k) | Class II | Active |
| Quanta Plex Sle Profile 8 | K040160 | FDA 510(k) | Class II | Active |
| Quanta Lite M2 Ep (mit3) Elisa | K052262 | FDA 510(k) | Class II | Active |
| Quanta Lite Sp100 Elisa | K050662 | FDA 510(k) | Class II | Active |
| Nova Lite(tm) Dsdna | K880742 | FDA 510(k) | Class II | Active |
| Quanta Lite Pr3 | K955021 | FDA 510(k) | Class II | Active |
| Quanta Lite Aca Screen (hrp) | K953291 | FDA 510(k) | Class II | Active |
| Quanta Flash Pr3, Quanta Flash Mpo, Quanta Flash Gbm | K112545 | FDA 510(k) | Class II | Active |
| QUANTA Flash HMGCR Reagents | K180975 | FDA 510(k) | Class II | Active |
| Nova Lite(tm) Ana | K880736 | FDA 510(k) | Class II | Active |
| Quanta Lite(tm) Thyroid T Elisa | K930486 | FDA 510(k) | Class II | Active |
| Quanta Lite Tpo Elisa | K981857 | FDA 510(k) | Class II | Active |
| Quanta Flash Sm, Quanta Flash Rnp, Quanta Flash Sm Calibrators, Quanta Flash Rnp Calibrators, Quanta Flash Sm Controls, | K123593 | FDA 510(k) | Class II | Active |
| Nova Gel(tm) Jo-1 | K892897 | FDA 510(k) | Class II | Active |
| Quanta Lite Ss-B Elisa | K922832 | FDA 510(k) | Class II | Active |
| Quanta Plex Ena Profile 6 | K031450 | FDA 510(k) | Class II | Active |
| Quanta Lite Asca (s. Cerevisiae) Iga Elisa | K000733 | FDA 510(k) | Class II | Active |
| Nova Gel(tm) T Jo-1 | K896462 | FDA 510(k) | Class II | Active |
| Quanta Lite Igg Gliadin Elisa | K964985 | FDA 510(k) | Class II | Active |
| Quanta Lite Lkm-1 Elisa | K000535 | FDA 510(k) | Class II | Active |
| Quanta Lite H-Ttg (human Tissue Transglutaminase) Iga Elisa | K011566 | FDA 510(k) | Class II | Active |
| Quanta Lite Asca (s. Cerevisiae) Igg Elisa | DEN000007 | FDA 510(k) | Class II | Active |
| Quanta Lite(tm) Jo-1 Elisa Kit | K926562 | FDA 510(k) | Class II | Active |
| Nova Lite Endomysial | K980312 | FDA 510(k) | Class II | Active |