| DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET (K133083) | Diazyme Laboratories | 2014-06-24 |
| IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY (K132801) | Siemens Healthcare Diagnostics, Inc. | 2014-05-28 |
| DUET SYSTEM (K130775) | Bioview , Ltd. | 2014-05-09 |
| FREELITE HUMAN LAMBDA FREE KIT (K140396) | The Binding Site Group , Ltd. | 2014-04-16 |
| HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS (K140664) | The Binding Site Group , Ltd. | 2014-04-16 |
| HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII (K140105) | The Binding Site | 2014-03-18 |
| IFA 40: HEP-20-10 (K131791) | Euroimmun US | 2014-02-26 |
| IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH (K133404) | Phadia AB | 2014-02-24 |
| QUANTA FLASH CENTROMERE (K123880) | Inova Diagnostics, Inc. | 2014-02-07 |
| GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT (K131330) | Gold Standard Diagnostics | 2014-01-28 |
| CYTOSCAN(R) DX (DEN130018) | Affymetrix, Inc. | 2014-01-17 |
| CALPREST (K130945) | Eurospital S.P.A. | 2014-01-16 |
| BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER (K130122) | Beckman Coulter, Inc. | 2014-01-07 |
| ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY (K131821) | Phadia US, Inc. | 2013-12-23 |
| HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT (K132555) | The Binding Site | 2013-12-20 |
| AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK (K132082) | Aesku Diagnostics | 2013-12-05 |
| ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY (K124006) | Illumina, Inc. | 2013-11-19 |
| ILLUMINA MISEQDX PLATFORM (DEN130011) | Illumina, Inc. | 2013-11-19 |
| ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY (K132750) | Illumina, Inc. | 2013-11-19 |
| IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA (K123713) | Immco Diagnostics, Inc. | 2013-10-25 |
| BIOPLEX 2200 APLS IGM (K130528) | Bio-Rad Laboratories | 2013-10-21 |
| BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI (K130053) | Bio-Rad Laboratories, Inc. | 2013-09-19 |
| PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY (K130010) | Nanostring Technologies | 2013-09-06 |
| AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES (K122197) | Phadia US, Inc. | 2013-08-28 |
| BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY (K130268) | Becton, Dickinson & CO | 2013-08-23 |
| ANA SCREEN ELISA (IGG) (K131185) | Euroimmun US | 2013-07-15 |
| IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H (K131738) | Phadia AB | 2013-07-10 |
| HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS (K123256) | The Binding Site Group , Ltd. | 2013-07-03 |
| IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM (K123275) | Phadia AB | 2013-06-28 |
| CELLTRACKS ANALYZER II SYSTEM (K130794) | Veridex, LLC | 2013-06-20 |
| HUMAN ALBUMIN CSF KIT (K121045) | The Binding Site Group , Ltd. | 2013-06-19 |
| EUROIMMUN ANTI-NRNP/SM ELISA (IGG) (K123261) | Euroimmun US | 2013-06-12 |
| DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET (K123785) | Diazyme Laboratories | 2013-06-07 |
| HUMAN CAERULOPLASMIN KIT (K122965) | The Binding Site Group , Ltd. | 2013-06-03 |
| HUMAN IGA CSF KIT FOR USE ON SPAPLUS (K120901) | The Binding Site Group , Ltd. | 2013-05-30 |
| FREND PSA PLUS (REAGENT CARTRIDGE) (K124056) | Nanoentek, Inc. | 2013-05-29 |
| HUMAN IGG CSF KIT (K120749) | The Binding Site Group , Ltd. | 2013-05-17 |
| HUMAN IGM CSF KIT (K120750) | The Binding Site Group , Ltd. | 2013-05-17 |
| QUANTA FLASH ENA7 (K122923) | Inova Diagnostics, Inc. | 2013-05-07 |
| QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, (K123593) | Inova Diagnostics, Inc. | 2013-04-17 |
| HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS (K122304) | The Binding Site Group , Ltd. | 2013-04-15 |
| EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) (K113439) | Euroimmun US | 2013-04-12 |
| EUROIMMUN ANTI-ENA POOL ELISA (IGG) (K112996) | Euroimmun US | 2013-04-09 |
| IMMULITE 2000 ANTI-CCP IGG ASSAY (K121576) | Siemens Healthcare Diagnostics, Inc. | 2013-04-04 |
| HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER (K120056) | The Binding Site Group , Ltd. | 2013-04-01 |
| HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT (K113823) | The Binding Site Group , Ltd. | 2013-03-27 |
| AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES (K121156) | Phadia AB | 2013-03-13 |
| QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA (K120817) | Inova Diagnostics, Inc. | 2013-02-26 |
| TRANSFERRIN KIT FOR USE ON THE SPAPLUS (K120236) | The Binding Site Group , Ltd. | 2013-02-13 |
| GENASIS SCANVIEW SYSTEM (K122554) | Applied Spectral Imaging , Ltd. | 2013-02-07 |
| IMMUNOCAP ALLERGEN K82 (K121463) | Thermo Fisher Scientific | 2013-01-29 |
| APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER (K122062) | Gen-Probe, Inc. | 2013-01-09 |
| STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT (K121046) | Kronus Market Development Associates, Inc. | 2012-12-20 |
| ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR (K123046) | Siemens Healthcare Diagnostics, Inc. | 2012-12-20 |
| AP 72OS SEMI-AUTOMATED INSTRUMENT (K112910) | Hitachi Chemical Diagnostics, Inc. | 2012-12-20 |
| GLIADIN IGA AND GLIADIN LGA (K113377) | Grifols USA, LLC | 2012-12-14 |
| CELLTRACKS AUTOPREP SYSTEM (K122821) | Veridex, LLC | 2012-12-13 |
| COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160 (K122722) | Roche Diagnostics | 2012-11-29 |
| IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS (K113020) | Immco Diagnostics, Inc. | 2012-10-25 |
| AESKUSLIDES ANA HEP-2 (K120889) | Aesku Diagnostics | 2012-10-15 |
| ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR (K122599) | Siemens Healthcare Diagnostics, Inc. | 2012-10-03 |
| DIAZYME HSCRP POC TEST KIT (K121558) | Diazyme Laboratories | 2012-09-21 |
| QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS (K113863) | Inova Diagnostics, Inc. | 2012-09-20 |
| IMMUNOCAP ALLERGEN COMPONENTS BUNDLE (K113841) | Phadia US, Inc. | 2012-09-13 |
| EUROIMMUN ANTI-LKM-1 ELISA(LGG) (K112223) | Euroimmun US | 2012-09-11 |
| EUROIMMUN ANTI-SLA/LP ELISA(LGG) (K112221) | Euroimmun US | 2012-09-11 |
| ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5 (K112624) | Roche Diagnostics | 2012-09-10 |
| HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS (K122066) | The Binding Site Group , Ltd. | 2012-08-30 |
| INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT (K120169) | Grifols USA, LLC | 2012-08-24 |
| HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) (K113809) | Hitachi Chemical Diagnostics, Inc. | 2012-08-17 |
| QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM (K112545) | Inova Diagnostics, Inc. | 2012-07-31 |
| HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO (K113349) | The Binding Site Group , Ltd. | 2012-07-11 |
| ANA-SCREEN WITH MDSS (K113610) | Bio-Rad Laboratories | 2012-07-09 |
| THE HELENA V8 IMMUNODISPLACEMENT KIT (K111369) | Helena Laboratories Uk, Ltd. | 2012-06-26 |
| ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY (K112414) | Phadia US, Inc. | 2012-06-22 |
| KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT (K111956) | Kronus Market Development Associates, Inc. | 2012-05-30 |
| K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR (K121232) | Kamiya Biomedical Company | 2012-05-24 |
| TINA-QUANT ALBUMIN GEN.2 (K113072) | Roche Diagnostics Operations | 2012-05-14 |
| BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS (K103834) | Bio-Rad Laboratories | 2012-03-30 |
| RNARETAIN (K113420) | Asuragen, Inc. | 2012-03-16 |
| HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS (K103824) | The Binding Site | 2012-02-27 |
| IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE (DEN120001) | Phadia US, Inc. | 2012-02-15 |
| ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR (K110874) | Siemens Healthcare Diagnostics, Inc. | 2012-01-20 |
| CELLTRACKS AUTOPREP SYSTEM (K110406) | Veridex, LLC | 2012-01-20 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K112523) | Siemens Healthcare Diagnostics, Inc. | 2012-01-06 |
| ACCESS THYROGLOBULIN ANITBODY (K112933) | Beckman Coulter, Inc. | 2011-12-27 |
| IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS (K111919) | Phadia US, Inc. | 2011-12-22 |
| CELLTRACKS ANALYER II (K113181) | Veridex, LLC | 2011-12-12 |
| ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM (K102425) | Zeus Scientific, Inc. | 2011-12-12 |
| IMMULISA SCI-70 ANTIBODY ELISA (K113143) | Immco Diagnostics, Inc. | 2011-12-02 |
| MULTI-ANALYTE DETECTION SYSTEMS (K112810) | Bio-Rad Laboratories | 2011-10-26 |
| QUANTA FLASH (TM) DGP SCREEN (K111414) | Inova Diagnostics, Inc. | 2011-10-20 |
| SCANVIEW SYSTEM (K110345) | Applied Spectral Imaging | 2011-10-19 |
| IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT (K103757) | Grifols | 2011-10-13 |
| RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM (K102673) | Phadia US, Inc. | 2011-09-30 |
| NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY (K101185) | Iris Molecular Diagnostics | 2011-09-20 |
| VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020 (K091960) | Abbott Molecular, Inc. | 2011-08-29 |
| AXIS-SHIELD ANTI-CCP (K110296) | Axis-Shield Diagnostics, Ltd. | 2011-08-18 |
| ADVIA CHEMISTRY FERRITIN (FRT) METHOD (K110736) | Siemens Healthcare Diagnostics, Inc. | 2011-08-17 |
| VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 (K100015) | Abbott Molecular, Inc. | 2011-08-09 |