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| K242531 | hycor biomedical | NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum h | April 23, 2025 |
| K212181 | phadia | ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Alle | August 3, 2022 |
| K220162 | hycor biomedical | Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, | February 18, 2022 |
| K193613 | hitachi chemical diagnostics | Allergen-Specific IgE Assay 12 Allergen Bundle | October 18, 2021 |
| K200825 | hycor biomedical | NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; | June 26, 2020 |
| K200279 | phadia | ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, | May 1, 2020 |
| K191510 | hycor biomedical | Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, | July 31, 2019 |
| K190315 | phadia | ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e23 | May 14, 2019 |
| K182793 | hitachi chemical diagnostics | AP3600 Automated Instrument | March 19, 2019 |
| K182479 | hycor biomedical | NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D | December 4, 2018 |
| K173726 | phadia | ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Pe | April 16, 2018 |
| K163370 | phadia | ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE | May 5, 2017 |
| K150597 | phadia | ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite | February 29, 2016 |
| K151029 | phadia | Phadia Prime | January 19, 2016 |
| K150854 | phadia | ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f4 | December 14, 2015 |
| K132801 | siemens healthcare diagnostics | IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY | May 28, 2014 |
| K122197 | phadia us | AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC I | August 28, 2013 |
| K131738 | phadia | IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP | July 10, 2013 |