| Elecsys CA 15-3 II (K171605) | Roche Diagnostics | 2018-02-20 |
| AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 (K172348) | Aesku.Diagnostics GmbH & Co. KG | 2018-02-16 |
| Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit (K172613) | The Binding Site Group , Ltd. | 2018-02-15 |
| Banyan BTI (DEN170045) | Banyan Biomarkers, Inc. | 2018-02-14 |
| KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit (K171731) | Kronus, Inc. | 2018-01-19 |
| MSD CRP Assay Kit and MESO SECTOR S 700 Instrument (K171498) | Meso Scale Diagnostics, LLC | 2018-01-12 |
| HYDRASHIFT 2/4 daratumumab, daratumumab Control (K172195) | Sebia | 2018-01-11 |
| QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer (K170993) | Inova Diagnostics, Inc. | 2017-12-22 |
| N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 (K171742) | Siemens Healthcare Diagnostics Products GmbH | 2017-11-17 |
| A1AT Genotyping Test (K171868) | Progenika Biopharma S.A., A Grifols Company | 2017-11-11 |
| VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody (DEN170030) | Ventana Medical Systems | 2017-10-27 |
| QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls (K163538) | Inova Diagnostics, Inc. | 2017-09-06 |
| QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls (K163525) | Inova Diagnostics, Inc. | 2017-09-05 |
| Atellica IM Ferritin Assay (K171642) | Siemens Healthcare Diagnostics, Inc. | 2017-08-31 |
| GenetiSure Dx Postnatal Assay (K163367) | Agilent Technologies, Inc. | 2017-08-11 |
| ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA (K163133) | Immco Diagnostics, Inc. | 2017-08-08 |
| ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA (K163177) | Immco Diagnostics, Inc. | 2017-07-28 |
| VITROS Chemistry Products hsCRP Reagent (K160712) | Ortho Clinical Diagnostics | 2017-07-14 |
| Ion PGM Dx System (K170299) | Life Technologies Corporation | 2017-06-22 |
| ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA (K162788) | Immco Diagnostics, Inc. | 2017-06-19 |
| FREND PSA PLUS (reagent cartridge) (K162378) | Nanoentek USA, Inc. | 2017-05-17 |
| ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE (K163370) | Phadia AB | 2017-05-05 |
| Optilite Rheumatoid Factor Kit (K162263) | The Binding Site Group , Ltd. | 2017-05-03 |
| 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia (DEN160026) | 23AndMe, Inc. | 2017-04-06 |
| C-Reactive Protein Kit for use on SPAPLUS (K161982) | The Binding Site Group | 2017-04-05 |
| NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit (K161258) | Inova Diagnostics, Inc. | 2017-02-03 |
| Ceruloplasmin (K161508) | Beckman Coulter Ireland, Inc. | 2017-01-09 |
| DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent (K162208) | Beckman Coulter, Inc. | 2017-01-09 |
| CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL (K161928) | Sebia | 2016-12-21 |
| xTAG Cystic Fibrosis 39 Kit v2 (K163347) | Luminex Molecular Diagnostics, Inc. | 2016-12-15 |
| xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR (K163336) | Luminex Molecular Diagnostics, Inc. | 2016-12-15 |
| Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker (K160915) | Roche Diagnostics | 2016-12-14 |
| Rheumatoid Factor (RF) Kit for use on SPAPLUS (K160070) | The Binding Site Group , Ltd. | 2016-12-07 |
| Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator (K153394) | Diazyme Laboratories | 2016-11-18 |
| Calprest NG (K160447) | Eurospital S.P.A. | 2016-11-10 |
| Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS (K161854) | The Binding Site Group , Ltd. | 2016-10-04 |
| BD MAX CT/GC/TV, BD MAX INSTRUMENT (K151589) | Becton, Dickinson and Company | 2016-09-06 |
| Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems (K161619) | Cepheid | 2016-08-29 |
| Optilite Low Level Albumin Kit (K153560) | The Binding Site Group , Ltd. | 2016-08-25 |
| Solana Trichomonas Assay (K161182) | Quidel Corporation | 2016-08-15 |
| ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. (K153551) | Axis-Shield Diagnostics Limited | 2016-08-04 |
| AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM (K153117) | Aesku Systems GmbH&Co.Kg | 2016-07-28 |
| ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls (K161899) | Phadia AB | 2016-07-28 |
| KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay (K161951) | Kronus, Inc. | 2016-07-22 |
| Image Navigator by Immuno Concepts (K160265) | Immuno Concepts, N.A. , Ltd. | 2016-06-17 |
| Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit (K160819) | The Binding Site Group , Ltd. | 2016-06-16 |
| Beta-2-Microglobulin (K161297) | Beckman Coulter Ireland, Inc. | 2016-06-07 |
| QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls (K152635) | Inova Diagnostics, Inc. | 2016-06-01 |
| KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay (DEN150030) | Kronus, Inc. | 2016-04-25 |
| QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls (K152013) | Inova Diagnostics, Inc. | 2016-04-11 |
| EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 (K151799) | Phadia AB | 2016-03-25 |
| ImmuLisa Enhanced Centromere Antibody ELISA (K151559) | Immco Diagnostics, Inc. | 2016-03-11 |
| QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument (K142993) | Orion Diagnostica, OY | 2016-03-10 |
| IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material (K152061) | Siemens Healthcare Diagnostics, Inc. | 2016-03-03 |
| ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite (K150597) | Phadia AB | 2016-02-29 |
| QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols (K151429) | Inova Diagnostics, Inc. | 2016-02-12 |
| Phadia Prime (K151029) | Phadia AB | 2016-01-19 |
| QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls (K152875) | Inova Diagnostics, Inc. | 2015-12-21 |
| Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit (K152389) | The Binding Site Group , Ltd. | 2015-12-18 |
| ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut (K150854) | Phadia AB | 2015-12-14 |
| AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 (K153150) | Inova Diagnostics, Inc. | 2015-11-24 |
| Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators (K151378) | Fujirebio Diagnostics,Inc. | 2015-11-24 |
| Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS (K151759) | The Binding Site Group , Ltd. | 2015-11-06 |
| Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit (K151565) | Cepheid | 2015-10-16 |
| VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 (K152433) | Ortho Clinical Diagnostics | 2015-09-24 |
| ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA (K143736) | Immco Diagnostics, Inc. | 2015-09-23 |
| QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 (K143754) | Inova Diagnostics, Inc. | 2015-09-21 |
| Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator (K150412) | The Binding Site Group , Ltd. | 2015-08-28 |
| Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit (K150658) | The Binding Site Group , Ltd. | 2015-08-26 |
| Elecsys CA-125 II assay (K143534) | Roche Professional Diagnostics | 2015-08-06 |
| Optilite IgG4 Kit (K150526) | The Binding Site Group , Ltd. | 2015-05-30 |
| Human Microalbumin kit for use on SPAPLUS (K143118) | The Binding Site Group , Ltd. | 2015-05-26 |
| LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators (K142895) | Fujirebio Diagnostics,Inc. | 2015-05-21 |
| EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE (K141827) | Euroimmun Us, Inc. | 2015-04-17 |
| NOVA View Automated Fluorescense Microscope (DEN140039) | Inova Diagnostics, Inc. | 2015-04-09 |
| NOVA Lite DAPI ANA Kit (K150155) | Inova Diagnostics, Inc. | 2015-04-08 |
| ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA (K142781) | Immco Diagnostics, Inc. | 2015-03-31 |
| AmpliVue Trichomonas Assay (K143329) | Quidel Corporation | 2015-03-17 |
| QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS (K141655) | Inova Diagnostics, Inc. | 2015-03-05 |
| 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS) (DEN140044) | 23AndMe | 2015-02-19 |
| QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS. (K141274) | Inova Diagnostics, Inc. | 2015-02-13 |
| ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 (K141375) | Phadia US, Inc. | 2015-02-13 |
| QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS (K141328) | Inova Diagnostics, Inc. | 2015-02-12 |
| QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS (K141210) | Inova Diagnostics, Inc. | 2015-01-29 |
| MAMMAPRINT FFPE (K141142) | Agendia | 2015-01-23 |
| MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING (K143483) | Sebia | 2015-01-08 |
| FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit (K141689) | Qualigen, Inc. | 2015-01-07 |
| The Optilite IgG3 kit (K142735) | The Binding Site Group , Ltd. | 2014-12-21 |
| PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM (DEN140010) | Wallac OY | 2014-12-15 |
| PLAC TEST FOR LP-PLA2 ACTIVITY (K141575) | Diadexus, Inc. | 2014-12-15 |
| EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) (K140224) | Euroimmun US | 2014-12-09 |
| PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY (K141771) | Nanostring Technologies, Inc. | 2014-11-07 |
| IG_PLEX CELIAC DGP PANEL (K140691) | Sqi Diagnostics Systems, Inc. | 2014-11-06 |
| ELIA SCL-70S IMMUNOASSAY (K140493) | Phadia GmbH | 2014-10-30 |
| ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO (K140225) | Phadia US, Inc. | 2014-10-27 |
| Urine/CSF Albumin, Urine/CSF Albumin Calibrator (K142346) | Beckman Coulter Ireland, Inc. | 2014-10-15 |
| EIA SMDP IMMUNOASSAY (K132631) | Phadia US, Inc. | 2014-08-29 |
| ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT (DEN140001) | Kronus Market Development Associates, Inc. | 2014-08-20 |
| HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS (K140686) | The Binding Site Group , Ltd. | 2014-08-06 |
| OPTILITE C1 INACTIVATOR KIT (K141100) | The Binding Site Group , Ltd. | 2014-07-18 |