| AutoBlot System 36 | 08887581002256 | Class A | |
| AutoBlot System 48 | 08887581002263 | Class A | |
| AutoScan PRO 4.0 | 08887581002171 | Class A | |
| MP Diagnostics ASSURE HEV lgM Rapid Test | 08887581000702 | Unknown class | |
| MP Diagnostics ASSURE H. pylori Antigen Rapid Test | 08887581001235 | Unknown class | |
| MP Diagnostics ASSURE H. pylori Rapid Test | 08887581000740 | Unknown class | |
| MP Diagnostics ASSURE TB Rapid Test | 08887581000757 | Unknown class | |
| MP Diagnostics HBsAg ELISA 4.1 | 08887581000610 | Unknown class | |
| MP Diagnostics HBsAg ELISA 4.1 | 08887581001006 | Unknown class | |
| MP Diagnostics Helico Blot 2.1 | 08887581000252 | Unknown class | |
| MP Diagnostics Helico Blot 2.1 | 08887581000269 | Unknown class | |
| MP Diagnostics HEV ELISA | 08887581000351 | Unknown class | |
| MP Diagnostics HEV ELISA 4.0 | 08887581001020 | Unknown class | |
| MP Diagnostics HEV lgM ELISA 3.0 | 08887581000535 | Unknown class | |
| MP Diagnostics HIV Ag/Ab Combo ELISA 4.0 | 08887581002126 | Unknown class | |
| MP Diagnostics HIV Ag/Ab Combo ELISA 4.0 | 08887581002133 | Unknown class | |
| MP Diagnostics MULTISURE® Dengue Ab/Ag Rapid Test | 08887581001792 | Unknown class | |
| MP Diagnostics MULTISURE HIV 1/2 Confirmatory Test | 08887581001839 | Unknown class | |
| MP Diagnostics MULTISURE HIV 1/2 Confirmatory Test Controls | 08887581002331 | Unknown class | |
| MP Diagnostics MULTISURE HIV Rapid Test | 08887581000665 | Unknown class | |
| MPure-32 aNAP System | 08887581002225 | Class A | |
| MPure-96 aNAP System | 08887581002232 | Class A | |
UDI Compass