| Virgo Anca Screen Kit | K973822 | FDA 510(k) | Class II | Active |
| Hemagen Ena Dsdna Kit (eia Method) | K962276 | FDA 510(k) | Class II | Active |
| Hemagen Ena Scl-70 Kit (eia Method) | K915282 | FDA 510(k) | Class II | Active |
| Raichem Lipid Calibrator | K022767 | FDA 510(k) | Class II | Active |
| Hemagen Ena Screen-6 Kit (eia Method) | K952077 | FDA 510(k) | Class II | Active |
| Virgo Panco Kit | K973824 | FDA 510(k) | Class II | Active |
| Raichem Hdl Cholesterol Using Cantrol Hdl Precipitating Tubes On The Cobas Mira Anaylzer | K023784 | FDA 510(k) | Class I | Active |
| Seratest Ena [ssa] Kit | K900617 | FDA 510(k) | Class II | Active |
| Hemagen Ena Sm/Rmp Kit (eia Method) | K950414 | FDA 510(k) | Class II | Active |
| Hemagen Ena Ss-A Kit (eia Method) | K946121 | FDA 510(k) | Class II | Active |
| Analyst Panels + Analytical Test Rotor | K010864 | FDA 510(k) | Class II | Active |
| Hemagen Anti Cardiolipin Screen | K971039 | FDA 510(k) | Class II | Active |
| Hemagen Rheumatoid Factor Kit (eia Method) | K962836 | FDA 510(k) | Class II | Active |
| Hemagen Ena Screen-6 Kit (eia Method) | K935828 | FDA 510(k) | Class II | Active |
| Seratest Ena [scl-70] Kit | K894411 | FDA 510(k) | Class II | Active |
| Virgo Beta 2 Glycoprotein Igm Antibody Kit | K992243 | FDA 510(k) | Class II | Active |
| Raichem Glucose Uv Reagent | K012668 | FDA 510(k) | Class II | Active |
| Raichem Glucose Uv (liquid) | K041052 | FDA 510(k) | Class II | Active |
| Virgo Ama Elisa Kit | K971909 | FDA 510(k) | Class II | Active |
| Hemagen Ena [rnp/Sm] Kit (eia Method) | K915272 | FDA 510(k) | Class II | Active |
| Raichem Bun Rate Reagent (liquid) | K041051 | FDA 510(k) | Class II | Active |
| Virgo B2 Glycoprotein I Iga Antibody Kit | K992241 | FDA 510(k) | Class II | Active |
| Raichem Creatinine Urine Standard | K011126 | FDA 510(k) | Class II | Active |
| Hemagen Ena Screening Kit (eia Method) | K952076 | FDA 510(k) | Class II | Active |
| Seratest Rf (hemagglutination) Kit | K855221 | FDA 510(k) | Class II | Active |
| Raichem Assayed Control Serum Level 1 & 2 | K031101 | FDA 510(k) | Class I | Active |
| Hemagen Ena Screening Kit | K910232 | FDA 510(k) | Class II | Active |