| Lumipulse G ß-Amyloid Ratio (1-42/1-40) (DEN200072) | Fujirebio Diagnostics,Inc. | 2022-05-04 |
| Zeus IFA ANA HEp-2 Test System, Zeus dIFine (K201956) | Zeus Scientific, Inc. | 2022-04-29 |
| Total Immunoglobulin E (IgE) (K220178) | Beckman Coulter, Inc. | 2022-03-23 |
| N Latex FLC kappa, N Latex FLC lambda (K212379) | Siemens Healthcare Diagnostics Products GmbH | 2022-03-02 |
| Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria (K220162) | Hycor Biomedical | 2022-02-18 |
| HYDRASHIFT 2/4 isatuximab (K203184) | Sebia | 2021-11-12 |
| N Latex FLC kappa, N Latex FLC lambda (K201496) | Siemens Healthcare Diagnostics Products GmbH | 2021-10-29 |
| Allergen-Specific IgE Assay 12 Allergen Bundle (K193613) | Hitachi Chemical Diagnostics, Inc. | 2021-10-18 |
| LIAISON Ferritin (K193650) | DiaSorin, Inc. | 2021-09-14 |
| EliA Rib-P (K202540) | Phadia AB | 2021-09-13 |
| EliA RNA Pol III (K202541) | Phadia AB | 2021-09-13 |
| Aptiva Celiac Disease IgG Reagent (K200230) | Inova Diagnostics, Inc. | 2021-08-26 |
| Diazyme PLAC® Test for Lp-PLA2 Activity (K203136) | Diazyme Laboratories, Inc. | 2021-08-06 |
| OncoMate MSI Dx Analysis System (K200129) | Promega Corporation | 2021-07-26 |
| N Latex FLC kappa, N Latex FLC lambda (K193047) | Siemens Healthcare Diagnostics Products GmbH | 2021-07-14 |
| EliA SmDP-S (K202067) | Phadia AB | 2021-07-14 |
| Aptiva Celiac Disease IgA Reagent (K193604) | Inova Diagnostics, Inc. | 2021-06-16 |
| A1AT Genotyping Test (K211115) | Progenika Biopharma S.A., A Grifols Company | 2021-05-13 |
| i-STAT TBI Plasma cartridge with the i-STAT Alinity System (K201778) | Abbott Laboratories | 2021-01-08 |
| Helix Genetic Health Risk App for late-onset Alzheimer’s disease (K192073) | Helix Opco, LLC | 2020-12-23 |
| NOVA Lite DAPI dsDNA Crithidia luciliae Kit (K192916) | Inova Diagnostics, Inc. | 2020-12-11 |
| MammaPrint (K201902) | Agendia, Inc. | 2020-11-05 |
| EUROIMMUN Anti-BP230-CF ELISA (IgG) (K193115) | Euroimmun Us, Inc. | 2020-09-17 |
| Lumipulse G CA15-3 (K192524) | Fujirebio Diagnostics,Inc. | 2020-09-04 |
| AncestryDNA Factor V Leiden Genetic Health Risk Test (K192944) | Ancestry Genomics, Inc. | 2020-08-13 |
| Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M (K193525) | HORIBA ABX SAS | 2020-06-26 |
| NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense (K200825) | Hycor Biomedical | 2020-06-26 |
| Yumizen C1200 CRP (K192028) | HORIBA ABX SAS | 2020-06-25 |
| K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) (K192727) | Kamiya Biomedical Company | 2020-05-20 |
| Lumipulse G CA19-9-N (K200997) | Fujirebio Diagnostics,Inc. | 2020-05-14 |
| ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine (K200279) | Phadia AB | 2020-05-01 |
| ADVIA Centaur CEA Assay (K200215) | Siemens Healthcare Disgnostics, Inc. | 2020-04-13 |
| ADVIA Centaur CA 125II (K200199) | Siemens Healthcare Diagnostics, Inc. | 2020-04-06 |
| Transferrin (K190495) | Biosystems S.A. | 2020-03-16 |
| Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor (K191562) | HORIBA ABX SAS | 2020-03-06 |
| Elecsys Anti-TSHR (K193313) | Roche Diagnostics | 2020-02-27 |
| Tina-quant C-Reactive Protein IV (K192072) | Roche Diagnostics Operations (Rdo) | 2020-02-21 |
| AmplideX Fragile X Dx & Carrier Screen Kit (DEN190023) | Asuragen, Inc. | 2020-02-21 |
| ADVIA Centaur BR (K193489) | Siemens Healthcare Diagnostics, Inc. | 2020-02-13 |
| ADVIA Centaur Total IgE (tIgE) (K193493) | Siemens Healthcare Diagnostics, Inc. | 2020-01-15 |
| EliA SymphonyS Immunoassay (K190710) | Phadia AB | 2019-11-29 |
| ADVIA Centaur CA 15-3 assay (K192777) | Siemens Healthcare Diagnostics, Inc. | 2019-11-22 |
| CRP Vario (K192118) | SENTINEL CH. SpA | 2019-11-08 |
| A1AT Genotyping Test (K192858) | Progenika Biopharma S.A., A Grifols Company | 2019-11-05 |
| CAPI 3 Immunotyping, Capillarys 3 Tera (K192095) | Sebia | 2019-11-01 |
| Maverick RNP Assay and Maverick Diagnostic System (K191085) | Genalyte, Inc. | 2019-10-25 |
| ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device (K191807) | ALPCO | 2019-10-25 |
| Lumpipulse G CA19-9-N (K191973) | Fujirebio Dianostics, Inc. | 2019-10-22 |
| Yumizen C1200 CRP (K191993) | HORIBA ABX SAS | 2019-10-03 |
| Buhlmann fCAL turbo and CALEX Cap (K191718) | Buhlmann Laboratories AG | 2019-09-24 |
| Human IgA liquid reagent kit for Use on SPAPlus (K192116) | The Binding Site Group , Ltd. | 2019-09-04 |
| Optilite IgA Kit (K191985) | The Binding Site Group , Ltd. | 2019-08-19 |
| Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae (K191510) | Hycor Biomedical | 2019-07-31 |
| Optilite IgM Kit (K191635) | The Binding Site Group , Ltd. | 2019-07-15 |
| Calprest, EasyCal (K191589) | Eurospital S.P.A. | 2019-07-10 |
| CalprestNG, EasyCal (K191592) | Eurospital S.P.A. | 2019-07-10 |
| Human IgM Kit for use on SPAPlus (K191465) | The Binding Site Group , Ltd. | 2019-06-27 |
| BUHLMANN fCAL turbo (K190784) | Buhlmann Laboratories AG | 2019-06-25 |
| Optilite IgM CSF Kit (K190686) | The Binding Site Group , Ltd. | 2019-05-28 |
| ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat (K190315) | Phadia AB | 2019-05-14 |
| N Latex FLC kappa, N Latex FLC lambda (K190879) | Siemens Healthcare Diagnostics Products GmbH | 2019-05-03 |
| HYDRASHIFT 2/4 daratumumab (K190851) | Sebia | 2019-05-02 |
| QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents (K190088) | Inova Diagnostics, Inc. | 2019-04-17 |
| AP3600 Automated Instrument (K182793) | Hitachi Chemical Diagnostics, Inc. | 2019-03-19 |
| EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay (K181871) | Phadia AB | 2019-03-01 |
| EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) (K183313) | Euroimmun Us, Inc. | 2019-02-28 |
| Optilite IgA CSF Kit (K183151) | The Binding Site Group , Ltd. | 2019-01-23 |
| BD MAX CTGCTV2, BD MAX System (K182692) | Becton, Dickinson and Company | 2019-01-08 |
| LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device (K182698) | DiaSorin, Inc. | 2018-12-26 |
| EliA SmDP Immunoassay (K183007) | Phadia AB | 2018-12-24 |
| EliA RF IgM Immunoassay (K182747) | Phadia AB | 2018-12-18 |
| NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus (K182479) | Hycor Biomedical | 2018-12-04 |
| EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay (K182353) | Phadia AB | 2018-11-27 |
| Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit (K180607) | Kronus, Inc. | 2018-11-23 |
| Tina-quant Transferrin ver.2 (urine application) (K182095) | Roche Diagnostics Operations (Rdo) | 2018-11-05 |
| N Latex FLC kappa assay, N Latex FLC lambda assay (K182098) | Siemens Healthcare Diagnostics Products GmbH | 2018-11-01 |
| Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts (K180202) | Immuno Concepts, N.A. , Ltd. | 2018-10-19 |
| QUANTA Flash Calprotectin and Fecal Extraction Device (K180971) | Inova Diagnostics, Inc. | 2018-10-16 |
| Optilite High Sensitivity C-Reactive Protein Kit (K180099) | The Binding Site Group , Ltd. | 2018-10-12 |
| CRP Vario (K173833) | SENTINEL CH. SpA | 2018-09-27 |
| Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit (K173732) | The Binding Site Group , Ltd. | 2018-08-23 |
| EliA M2 Immunoassay (K181556) | Phadia AB | 2018-07-13 |
| Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay (K181438) | Diazyme Laboratories, Inc. | 2018-06-26 |
| QUANTA Flash HMGCR Reagents (K180975) | Inova Diagnostics, Inc. | 2018-06-25 |
| EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay (K181329) | Phadia AB | 2018-06-25 |
| OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test (K181436) | SEKISUI Diagnostics, LLC | 2018-06-22 |
| Elecsys CA 15-3 II (K181492) | Roche Diagnostics | 2018-06-22 |
| ImmuGlo HEp-2 Elite IFA (K172745) | Immco Diagnostics, Inc. | 2018-06-05 |
| BUHLMANN fCAL ELISA (K181012) | Buhlmann Laboratories AG | 2018-06-04 |
| EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern (K172582) | Euroimmun Us, Inc. | 2018-05-24 |
| VENTANA CD30 (Ber-H2) RxDx Assay (K172471) | Ventana Medical Systems, Inc. | 2018-05-08 |
| EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern (K172252) | Euroimmun Us, Inc. | 2018-04-20 |
| EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern (K172244) | Euroimmun Us, Inc. | 2018-04-20 |
| ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut (K173726) | Phadia AB | 2018-04-16 |
| ImmuLisa Enhanced RNA POL III Antibody ELISA (K172078) | Immco Diagnostics, Inc. | 2018-03-30 |
| AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin (K172461) | Aesku.Diagnostics GmbH & Co. KG | 2018-03-23 |
| Diazyme Lipoprotein (a) Assay (K180074) | Diazyme Laboratories, Inc. | 2018-03-22 |
| EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay (K173792) | Phadia AB | 2018-03-13 |
| ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip (K173704) | Phadia AB | 2018-03-02 |
| Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls (K172868) | The Binding Site Group , Ltd. | 2018-02-28 |