| QUANTA Flash® Ro60 Controls | 701147 | FDA UDI | Class I | Active |
| QUANTA LITE® R h-tTG IgA ELISA Kit, Bulk (Lab Corp) | 704605.10L | FDA UDI | Class II | Active |
| QUANTA Lite® Gliadin IgG ELISA | 708650 | FDA UDI | Class II | Active |
| QUANTA Lite® ACA Screen III | 708620 | FDA UDI | Class II | Active |
| QUANTA LITE® B2 GPI IgM ELISA Bulk Pack Kit (Lab Corp) | 708670.10L | FDA UDI | Class II | Active |
| QUANTA Lite® GBM ELISA Bulk Pack | 708740.10 | FDA UDI | Class II | Active |
| QUANTA Lite® SS-B ELISA | 708575 | FDA UDI | Class II | Active |
| QUANTA Lite® R h-tTG IgG ELISA | 704610 | FDA UDI | Class II | Active |
| QUANTA Lite® Sm ELISA | 708560 | FDA UDI | Class II | Active |
| QUANTA Flash® GBM Reagents | 701143 | FDA UDI | Class II | Active |
| QUANTA Lite® PR3 SC ELISA Bulk Pack | 704660.10 | FDA UDI | Class II | Active |
| QUANTA Lite® Gliadin IgG II ELISA | 704520 | FDA UDI | Class II | Active |
| NOVA Gel® Scl-70 “T” Extractable Nuclear Autoantibody Reagents | 708475 | FDA UDI | Class II | Unknown |
| QUANTA Lite® SS-A ELISA | 708570 | FDA UDI | Class II | Active |
| QUANTA Lite® h-tTG IgA ELISA Bulk Pack | 708760.10 | FDA UDI | Class II | Active |
| QUANTA Lite® β2GPI IgA | 708675 | FDA UDI | Class II | Active |
| QUANTA Lite® β2GPI IgM ELISA | 708670 | FDA UDI | Class II | Active |
| NOVA Lite® HEp-2 External EB Kits | 704235 | FDA UDI | Class II | Unknown |
| QUANTA Flash® DGP Screen Controls | 701112 | FDA UDI | Class I | Active |
| NOVA Gel®Sm/RNP “S” Extractable Nuclear Autoantibody Reagents | 708410 | FDA UDI | Class II | Unknown |
| QUANTA Flash® aCL IgG Reagents | 701230 | FDA UDI | Class II | Active |
| QUANTA Lite® ACA IgM III ELISA Bulk Pack | 708630.10 | FDA UDI | Class II | Active |
| QUANTA Flash® h-tTG IgG Reagents | 701108 | FDA UDI | Class II | Active |
| QUANTA Lite® PR3 SC ELISA | 704660 | FDA UDI | Class II | Active |
| QUANTA Lite® β2GPI IgA ELISA Bulk Pack | 708675.10 | FDA UDI | Class II | Active |
| QUANTA LITE®Calprotectin Extended Range | 704860 | FDA UDI | Class II | Active |
| NOVA Lite® ANCA (Formalin) Kit with DAPI | 708300 | FDA UDI | Class II | Unknown |
| Aptiva® APS IgM Calibrators | 725141 | EUDAMEDFDA UDI | Class B | Active |
| Aptiva® APS IgG Controls | 725102 | EUDAMEDFDA UDI | Class B | Active |
| Aptiva® Multi-Analyte Instrument | AP5000 | EUDAMEDFDA UDI | Class A | Active |
| Quanta Lite(tm) Igg (hrp) | K946034 | FDA 510(k) | Class II | Active |
| Quanta Lite(tm) Histone Elisa | K934053 | FDA 510(k) | Class II | Active |
| AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 | K153150 | FDA 510(k) | Class II | Active |
| NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit | K161258 | FDA 510(k) | Class II | Active |
| Quanta Lite H-Ttg/Dgp Screen | K070083 | FDA 510(k) | Class II | Active |
| Quanta Lite Rebella Igg | K971304 | FDA 510(k) | Class II | Active |
| Quanta Lite Rf Iga Elisa | K983084 | FDA 510(k) | Class II | Active |
| Quanta Lite Toxoplasma Igg | K971441 | FDA 510(k) | Class II | Active |
| Quanta Lite Omp Plus Elisa | K081248 | FDA 510(k) | Class II | Active |
| NOVA Lite DAPI dsDNA Crithidia luciliae Kit | K192916 | FDA 510(k) | Class II | Active |
| Quanta Lite Ccp3.1 Igg/Iga Elisa | K072944 | FDA 510(k) | Class II | Active |
| Quanta Lite B2 Gpi Screen | K980230 | FDA 510(k) | Class II | Active |
| Quanta Lite Gliadin Iga Ii | K052143 | FDA 510(k) | Class II | Active |
| Nova Gel(tm) Sm/Rnp | K881181 | FDA 510(k) | Class II | Active |
| Quanta Lite Ccp3 Igg Elisa | K052264 | FDA 510(k) | Class II | Active |
| Quanta Lite Ss-A Elisa | K922830 | FDA 510(k) | Class II | Active |
| Quanta Flash Ro52, Quanta Flash Ro52 Calibrators, And Quanta Flash Ro52 Controls | K141655 | FDA 510(k) | Class II | Active |
| Quanta Plex Ena Profile 4 | K011140 | FDA 510(k) | Class II | Active |
| Quanta Lite Celiac Dgp Screen | K062708 | FDA 510(k) | Class II | Active |
| Quanta Lite(tm) Thyroid M Elisa | K930485 | FDA 510(k) | Class II | Active |