| Analyzer FT MTBDR 2.0 FC XT | 04049055003983 | Class A | |
| Analyzer GENERIC HBV VL 2.0 FCXT | 04049055003945 | Class A | |
| Analyzer GENERIC HIV-1 VL 2.0 FCXT | 04049055003976 | Class A | |
| Analyzer LA Gastrointestinal 2 PCR 1 | 04049055004003 | Class A | |
| Analyzer LA Gastrointestinal 2 PCR 2 | 04049055004010 | Class A | |
| Analyzer LA Gastrointestinal PCR 1 | 04049055003952 | Class A | |
| Analyzer LA Gastrointestinal PCR 2 | 04049055003969 | Class A | |
| FluoroCycler® 12 | 04049055002993 | Class A | |
| FluoroCycler® XT | 04049055003396 | Class A | |
| FluoroLyse VER 1.0 | 04049055002849 | Class A | |
| FluoroSoftware® IVD | 04049055003822 | Class A | |
| FluoroSoftware® XT-IVD | 04049055003839 | Class A | |
| FluoroType® BKV HT VER 1.0 | 04049055003518 | Class C | |
| FluoroType® CT VER 1.0 | 04049055003037 | Unknown class | |
| FluoroType® Factor II VER 1.0 | 04049055002665 | Unknown class | |
| FluoroType® Factor V VER 1.0 | 04049055002689 | Unknown class | |
| FluoroType® HH C282Y VER 1.0 | 04049055002696 | Unknown class | |
| FluoroType® HH H63D VER 1.0 | 04049055002719 | Unknown class | |
| FluoroType® HLA-B27 VER 1.0 | 04049055003013 | Unknown class | |
| FluoroType® HSV VER 1.0 | 04049055002870 | Unknown class | |
| FluoroType® LCT VER 1.0 | 04049055002757 | Unknown class | |
| FluoroType® MRSA VER 3.0 | 04049055003662 | Class C | |
| FluoroType® MTBDR VER 2.0 | 04049055003938 | Class C | |
| FluoroType® MTB VER 1.0 | 04049055003754 | Unknown class | |
| FluoroType® MTHFR C677T VER 1.0 | 04049055002795 | Unknown class | |
UDI Compass