| Measles IgG IFA Slide Only Kit | 903101 | FDA UDI | Class I | Active |
| Cytomegalovirus / CMV IgM IFA 96 Test | 902112 | FDA UDI | Class II | Active |
| Varicella-Zoster Virus / VZV IgG IFA Slide Only Kit | 902801 | FDA UDI | Class II | Active |
| Chlamydia trachomatis / C. trach IgG IFA 96 Test | 903000 | FDA UDI | Class I | Active |
| Herpes Simplex Virus Type 1 / HSV-1 IgG IFA 96 Test | 902500 | FDA UDI | Class II | Active |
| Herpes Simplex Virus Type 2 / HSV-2 IgG IFA Slides Only Kit | 902601 | FDA UDI | Class II | Active |
| Mumps IgG IFA Slide Only Kit | 903201 | FDA UDI | Class I | Active |
| Toxo IgG IFA 204 Test | 902020 | FDA UDI | Class II | Active |
| Measles IgG IFA 96 Test | 903100 | FDA UDI | Class I | Active |
| Anti-nDNA IgG IFA 96 Test | 902420 | FDA UDI | Class II | Active |
| Chlamydia trachomatis / C. trach IgG IFA Slide Only Kit | 903001 | FDA UDI | Class I | Active |
| Herpes Simplex Virus Type 2 / HSV-2 IgG IFA 96 Test | 902600 | FDA UDI | Class II | Active |
| Cytomegalovirus / CMV IgG IFA 96 Test | 902111 | FDA UDI | Class II | Active |
| ANA/HEp-2 IgG IFA 1200 Test | 902370 | FDA UDI | Class II | Active |
| Mumps IgG IFA 96 Test | 903200 | FDA UDI | Class I | Active |
| ANA/HEp-2 IgG IFA 120 Test | 902390 | FDA UDI | Class II | Active |
| Toxo IgG IFA Slide Only Kit | 902021 | FDA UDI | Class II | Active |
| ANA/HEp-2 IgG IFA 96 Test | 902344 | FDA UDI | Class II | Active |
| Rubella IgG IFA Slide Only Kit | 902701 | FDA UDI | Class II | Active |
| Varicella-Zoster Virus / VZV IgG IFA 96 Test | 902800 | FDA UDI | Class II | Active |
| Herpes Simplex Virus Type 1 / HSV-1 IgG IFA Slide Only Kit | 902501 | FDA UDI | Class II | Active |
| Rubella IgG IFA 96 Test | 902700 | FDA UDI | Class II | Active |
| ANA/HEp-2 IgG IFA 180 Test | 902345 | FDA UDI | Class II | Active |
| Toxo IgG IFA 120 Test | 902010 | FDA UDI | Class II | Active |
| ANA/HEp-2 IgG IFA 600 Test | 902360 | FDA UDI | Class II | Active |
| Raichem Bun Rate Reagent | K012649 | FDA 510(k) | Class II | Active |
| Seratest Ena [ss-B] Kit | K862700 | FDA 510(k) | Class II | Active |
| Hemagen Ena [jo-1] Kit (eia Method) | K915420 | FDA 510(k) | Class II | Active |
| Hemagen Ena Jo-1 Kit (eia Method) | K946124 | FDA 510(k) | Class II | Active |
| Raichem Crp High Sensitivity Test System | K021194 | FDA 510(k) | Class II | Active |
| Hemagen Ena Sm Kit (eia Method) | K946123 | FDA 510(k) | Class II | Active |
| Hemagen Ena Screening Kit (eia Method) | K915058 | FDA 510(k) | Class II | Active |
| Hemagen Chagas' Kit (eia Method) | K930272 | FDA 510(k) | Class I | Active |
| Raichem Multi-Analyte Calibrator | K012250 | FDA 510(k) | Class II | Active |
| Hemagen Cardiolipin Antibody Kit (eia Method0 | K932373 | FDA 510(k) | Class II | Active |
| Pr 3 Antibody Kit | K973823 | FDA 510(k) | Class II | Active |
| Hemagen Ena (ss-A/Ss-B) Kit (eia Method) | K915234 | FDA 510(k) | Class II | Active |
| Hemagen C-Reactive Protein Kit (eia Method) | K944288 | FDA 510(k) | Class II | Active |
| Hemagen Cmv Igg Kit | K944438 | FDA 510(k) | Class II | Active |
| Modification To Raichem Calcium Reagent | K022049 | FDA 510(k) | Class II | Active |
| Hemagen Ena Ss-B Kit (eia Method) | K946120 | FDA 510(k) | Class II | Active |
| Raichem Phosporus Reagent | K003012 | FDA 510(k) | Class I | Active |
| Raichem Prealbumin Spia | K972812 | FDA 510(k) | Class I | Active |
| Raichem Ldl-Cholesterol Direct Reagent | K022772 | FDA 510(k) | Class I | Active |
| Hemagen Acl Iga Calibrator | K941840 | FDA 510(k) | Class II | Active |
| Hemagen Ena Scl-70 Kit (eia Method) | K946122 | FDA 510(k) | Class II | Active |
| Hemagen Ena [jo-I] Kit | K902139 | FDA 510(k) | Class II | Active |
| Raichem Calcium (ocpc) Liquid Reagent | K041009 | FDA 510(k) | Class II | Active |
| Virgo Beta 2 Glycoprotein Igg Antibody Kit | K992224 | FDA 510(k) | Class II | Active |
| Hemagen Crp 150 Kit (eia Method) | K960324 | FDA 510(k) | Class II | Active |