| K252775 | NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, B | January 16, 2026 |
| K252493 | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam ( | December 23, 2025 |
| K242531 | NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture R | April 23, 2025 |
| K220162 | Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria | February 18, 2022 |
| K200825 | NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE | June 26, 2020 |
| K191510 | Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides far | July 31, 2019 |
| K182479 | NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoide | December 4, 2018 |
| K081217 | HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM | May 22, 2008 |
| K080322 | HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200 | March 5, 2008 |
| K043433 | AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA | March 7, 2005 |
| K033744 | AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA | January 20, 2004 |
| K030741 | AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA | May 1, 2003 |
| K030397 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA | March 21, 2003 |
| K022945 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA | December 18, 2002 |
| K022944 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA | December 18, 2002 |
| K965094 | HYCOR ALLERGEN DISC | May 21, 1997 |
| K962729 | HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY | March 7, 1997 |
| K962731 | HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY | March 7, 1997 |
| K962730 | HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY | March 7, 1997 |
| K962728 | HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY | March 7, 1997 |