| DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH (K063655) | Dade Behring, Inc. | 2007-02-15 |
| MAMMAPRINT (DEN070009) | Agendia BV | 2007-02-06 |
| CERULOPLASMIN, MODEL 2055953 (K062114) | Roche Diagnostics Corp. | 2007-01-31 |
| WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401 (K062368) | Wako Chemicals USA, Inc. | 2007-01-31 |
| DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH (K063272) | Dade Behring, Inc. | 2007-01-26 |
| DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H (K063322) | Dade Behring, Inc. | 2007-01-24 |
| DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH (K063610) | Dade Behring, Inc. | 2007-01-11 |
| ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01 (K062787) | Phadia US, Inc. | 2006-12-29 |
| ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 (K062583) | Phadia US, Inc. | 2006-12-26 |
| STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK (K062924) | Dade Behring, Inc. | 2006-12-26 |
| IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP (K063057) | Diagnostic Products Corporation | 2006-12-22 |
| CELLSEARCH CIRCULATING TUMOR CELL KIT (K062013) | Veridex, LLC | 2006-12-14 |
| AESKULSKA BETA2-GLYCO-A (K062217) | Aesku, Inc. | 2006-12-13 |
| QUANTA LITE CELIAC DGP SCREEN (K062708) | Inova Diagnostics, Inc. | 2006-12-13 |
| EDIA ANTI-CCP (K062045) | Euro-Diagnostica AB | 2006-12-04 |
| FIDIS TM THYRO, MODEL MX002 (K061794) | Biomedical Diagnostics (Bmd) SA | 2006-11-21 |
| FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT (K062183) | The Binding Site, Ltd. | 2006-11-21 |
| FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 (K062746) | Medicon Hellas S.A | 2006-11-20 |
| QUANTA LITE PBC SCREEN IGG/IGA ELISA (K061842) | Inova Diagnostics, Inc. | 2006-10-18 |
| EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT (K061408) | Euroimmun Us, LLC | 2006-10-05 |
| ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) (K062516) | Beckman Coulter, Inc. | 2006-10-05 |
| ABX PENTRA 400 : CRP (K061138) | Horiba Abx | 2006-09-29 |
| DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH (K061852) | Dade Behring, Inc. | 2006-09-22 |
| DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL (K061990) | Dade Behring, Inc. | 2006-09-19 |
| MODIFICATION TO DIADEXUS PLAC TEST (K062234) | Diadexus, Inc. | 2006-09-11 |
| DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH (K061802) | Dade Behring, Inc. | 2006-09-11 |
| EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT. (K060700) | Euroimmun Us, LLC | 2006-09-08 |
| DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH (K061825) | Dade Behring, Inc. | 2006-09-06 |
| ELECSYS IGE II IMMUNOASSAY (K061970) | Roche Diagnostics | 2006-08-31 |
| DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H (K061845) | Dade Behring, Inc. | 2006-08-24 |
| ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 (K061165) | Sweden Diagnostics (Us), Inc. | 2006-08-03 |
| TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM (K061683) | Roche Diagnostics Corp. | 2006-07-21 |
| EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 (K061376) | Theratest Laboratories, Inc. | 2006-07-20 |
| ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS (K052407) | Fisher Diagnostics | 2006-07-18 |
| DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY (K061338) | Dade Behring, Inc. | 2006-07-06 |
| SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 (K061069) | Helena Laboratories | 2006-07-06 |
| ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227 (K061382) | Beckman Coulter, Inc. | 2006-07-06 |
| ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 (K060431) | Mbl International Corporation | 2006-06-19 |
| TAG-IT CYSTIC FIBROSIS KIT (K060627) | Tm Bioscience Corporation | 2006-06-07 |
| OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. (K060201) | Olympus America, Inc. | 2006-06-06 |
| IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA (K060157) | Immco Diagnostics, Inc. | 2006-05-25 |
| ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM (K052308) | Fisher Diagnostics | 2006-05-10 |
| STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK (K060369) | Dade Behring, Inc. | 2006-05-04 |
| FIDIS DSDNA (K060380) | Biomedical Diagnostics (Bmd) SA | 2006-05-02 |
| CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 (K060139) | Diagnostic Chemicals , Ltd. | 2006-04-28 |
| PHICAL TEST (DEN060001) | Genova Diagnostics | 2006-04-26 |
| TECHLAB ASCA-CHEK (K051927) | Techlab, Inc. | 2006-04-06 |
| FIDIS CELIAC (K053383) | Biomedical Diagnostics (Bmd) SA | 2006-03-29 |
| N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN (K053072) | Dade Behring, Inc. | 2006-03-28 |
| N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN (K053073) | Dade Behring, Inc. | 2006-03-28 |
| ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800 (K060543) | Clinical Micro Sensors, Inc. | 2006-03-28 |
| N ANTISERA TO HUMAN TRANSFERRIN (K053075) | Dade Behring, Inc. | 2006-03-16 |
| CELLTRACKS ANALYZER II (K060110) | Immunicon Corp. | 2006-03-16 |
| N ANTISERA TO HUMAN CERULOPLASMIN (K053074) | Dade Behring, Inc. | 2006-03-16 |
| FIDIS CONNECTIVE 10, MODEL MX006 (K053653) | Biomedical Diagnostics (Bmd) SA | 2006-03-13 |
| RDI HSFERRITIN KIT (K053211) | Reference Diagnostics, Inc. | 2006-03-13 |
| NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL (K053553) | Polymedco, Inc. | 2006-03-09 |
| FIDIS VASCULITIS, MODEL MX007 (K053012) | Biomedical Diagnostics (Bmd) SA | 2006-03-02 |
| FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H, (K052617) | Good Biotech Corp. | 2006-02-23 |
| EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM (K051489) | Euroimmun Us, LLC | 2006-02-16 |
| IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT (K060130) | Beckman Coulter, Inc. | 2006-02-13 |
| NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT (K052591) | Clinical Data, Inc. | 2006-02-09 |
| C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS (K053603) | Roche Diagnostics Corp. | 2006-02-09 |
| IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02 (K052793) | Pharmacia Diagnostics AB | 2006-02-07 |
| EL-ACL SCREEN; EL-ACL IGM, IGG, IGA (K060176) | Theratest Laboratories, Inc. | 2006-02-07 |
| ROCHE ELECSYS ANTI-TG (K053426) | Roche Diagnostics Corp. | 2006-02-07 |
| AESKULISA GLIA A AND AESKULISA GLIA G (K052439) | Aesku Diagnostics | 2006-02-07 |
| OPTIGEN ALLERGEN SPECIFIC IGE ASSAY (K051677) | Hitachi Chemical Diagnostics, Inc. | 2006-01-23 |
| ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800 (K051435) | Clinical Micro Sensors | 2006-01-19 |
| VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III (K052819) | Ortho-Clinical Diagnostics, Inc. | 2005-12-23 |
| DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE (K053109) | Dade Behring, Inc. | 2005-12-23 |
| K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET (K050944) | Kamiya Biomedical Co. | 2005-12-23 |
| VITROS CA 19-9 (K052889) | Fujirebio Diagnostics,Inc. | 2005-12-20 |
| IMMUNOSCAN RA ANTI-CCP TEST SYSTEM (K052133) | Eurodiagnostica | 2005-12-12 |
| WIESLAB CAP MPO-ANCA (K051455) | Eurodiagnostica | 2005-11-23 |
| IGD DIAGNOSTIC TEST KITS (K051299) | The Binding Site, Ltd. | 2005-11-23 |
| QUANTA LITE CCP3 IGG ELISA (K052264) | Inova Diagnostics, Inc. | 2005-11-23 |
| WIESLAB CAP PR-3 ANCA (K051458) | Eurodiagnostica | 2005-11-22 |
| ACETYLCHOLINE RECEPTOR AB (ARAB)RRA (K051144) | Ibl-Hamburg GmbH | 2005-11-18 |
| AESKULISA ASCA A (K051492) | Aesku, Inc. | 2005-11-14 |
| KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT (K051061) | Kronus Market Development Associates, Inc. | 2005-11-04 |
| QUANTA LITE M2 EP (MIT3) ELISA (K052262) | Inova Diagnostics, Inc. | 2005-10-27 |
| MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT (K052191) | Veridex, LLC | 2005-10-27 |
| ARCHITECT CA 19-9XR ASSAY (K052000) | Fujirebio Diagnostics,Inc. | 2005-10-25 |
| SENTINEL CERULOPLASMIN (K051456) | Sentinel Ch. Srl | 2005-10-21 |
| THERATEST EL-ANA PROFILES (K051066) | Theratest Laboratories, Inc. | 2005-10-07 |
| QUANTA LITE GLIADIN IGA II (K052143) | Inova Diagnostics, Inc. | 2005-10-04 |
| QUANTA LITE GLIADIN IGG II (K052142) | Inova Diagnostics, Inc. | 2005-10-04 |
| FIDIS CONNECTIVE 8 (K050286) | Biomedical Diagnostics (Bmd) SA | 2005-10-03 |
| FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER (K051915) | The Binding Site, Ltd. | 2005-09-06 |
| OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH (K051564) | Olympus America, Inc. | 2005-08-22 |
| FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 (K052082) | Beckman Coulter, Inc. | 2005-08-19 |
| QUANTIA IGE (K050493) | Biokit, S.A. | 2005-08-16 |
| QUANTIA BETA-2 MICROGLOBULIN (K050613) | Biokit, S.A. | 2005-08-16 |
| CRP DIAGNOSTIC ASSAY (K050836) | Sentinel Ch. Srl | 2005-08-08 |
| ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO (K051890) | Roche Diagnostics Corp. | 2005-08-04 |
| BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT (K042579) | The Binding Site | 2005-07-28 |
| DCL MICROALBUMIN ASSAY, MODEL 252-20 (K051191) | Diagnostic Chemicals , Ltd. | 2005-07-05 |
| VARELISA RECOMBI CTD SCREEN, MODEL 13096 (K050967) | Sweden Diagnostics (Germany) GmbH | 2005-06-28 |
| CAPILLARY'S IMMUNOTYPING (PN 2100) (K042939) | Sebia, Inc. | 2005-06-27 |