| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K101572) | Siemens Healthcare Diagnostics | 2011-08-01 |
| FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL (K103676) | Fujirebio Diagnostics,Inc. | 2011-07-19 |
| EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR (K101089) | Medica Corp. | 2011-07-13 |
| IGX PLEX CELIAC QUALITATIVE ASSAY (K102490) | Sqi Diagnostics Systems | 2011-06-02 |
| IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN (K101251) | Phadia AB | 2011-05-27 |
| CYFRA 21-1 EIA MODEL 211-10 (K100831) | Fujirebio Diagnostics,Inc. | 2011-05-26 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 (K100910) | Siemens Medical Solutions Diagnostics | 2011-05-11 |
| DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET (K103557) | Diazyme Laboratories | 2011-04-27 |
| APTIMA TRICHOMONAS VAGINALIS ASSAY (DEN110012) | Gen-Probe Incorporated | 2011-04-19 |
| DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 (K100344) | Siemens Healthcare Diagnostics | 2011-04-18 |
| DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604 (K100321) | Siemens Healthcare Diagnostics | 2011-04-12 |
| DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604 (K100375) | Siemens Healthcare Diagnostics, Inc. | 2011-04-06 |
| IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6 (K093987) | Siemens Healthcare Diagnostics, Inc. | 2011-03-28 |
| QUANTA FLASH H-TTG IGG (K101644) | Inova Diagnostics, Inc. | 2011-03-23 |
| EU-TTG IGA AND EU-TTG IGG (K102964) | Grifols USA, Inc. | 2011-03-07 |
| UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION (K100464) | Wako Chemicals USA, Inc. | 2011-02-23 |
| MAMMAPRINT (K101454) | Agendia | 2011-01-28 |
| PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115 (K101853) | Diadexus, Inc. | 2011-01-03 |
| CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 (K103502) | Veridex, LLC | 2010-12-21 |
| IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01 (K100999) | Phadia AB | 2010-12-15 |
| IMMULISA DSDNA ANTIBODY ELISA (K101319) | Immco Diagnostics, Inc. | 2010-12-09 |
| FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS (K102607) | Biomedical Diagnostics (Bmd) SA | 2010-12-03 |
| CCPOINT (K093908) | Euro-Diagnostica AB | 2010-12-01 |
| SCANVIEW HER2/NEU FISH SYSTEM (K101291) | Applied Spectral Imaging , Ltd. | 2010-11-23 |
| FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM (K100917) | Biomedical Diagnostics (Bmd) SA | 2010-11-03 |
| ORGENTEC RHEUMATOID FACTOR EIA (K100499) | Orgentec Diagnostika GmbH | 2010-10-27 |
| QUANTA FLASH H-TTG IGA (K094060) | Inova Diagnostics, Inc. | 2010-10-13 |
| IMMULISA PR3 ANTIBODY ELISA (K092600) | Immco Diagnostics, Inc. | 2010-10-07 |
| IMMULISA ANCA SCREEN ELISA (K092601) | Immco Diagnostics, Inc. | 2010-10-07 |
| IMMULISA MPO ANTIBODY ELISA (K092599) | Immco Diagnostics, Inc. | 2010-10-07 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K093107) | Siemens Healthcare Diagnostics | 2010-09-30 |
| EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM (K100017) | Euroimmun Us, Inc. | 2010-09-13 |
| TINA-QUANT ALBUMIN GEN 2 (K101203) | Roche Diagnostics | 2010-09-10 |
| COBAS 8000 MODULAR SERIES ANALYZER (K100853) | Roche Diagnostics Corp. | 2010-09-09 |
| SPAPLUS ANALYZER (K100455) | The Binding Site | 2010-09-03 |
| EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG) (K091969) | Euroimmun Us, Inc. | 2010-09-02 |
| EUROIMMUN ANTI-M2-3E ELISA (IGG) (K092736) | Euroimmun Us, Inc. | 2010-09-02 |
| BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K093954) | Bio-Rad Laboratories | 2010-08-24 |
| HUMAN IGA2 KIT FOR USE ON THE SPAPLUS (K100588) | The Binding Site Group , Ltd. | 2010-08-16 |
| ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 (K093459) | Phadia US, Inc. | 2010-08-13 |
| SPAPLUS (K100179) | The Binding Site Group , Ltd. | 2010-08-13 |
| ANTI-MUTATED CITRULLINATED VIMENTIN EIA (K092399) | Orgentec Diagnostika GmbH | 2010-07-01 |
| TINA-QUANT FERRITIN GEN. 4 (K100538) | Roche Diagnostics | 2010-06-22 |
| CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM (K091845) | Phadia US, Inc. | 2010-06-07 |
| AESKU PR3 (K091859) | Aesku Diagnostics | 2010-06-03 |
| HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS (K091556) | Instrumentation Laboratory CO | 2010-05-21 |
| THYRETAIN TM TSI REPORTER BIOASSAY (K092229) | Diagnostic Hybrids, Inc. | 2010-05-18 |
| K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR (K091486) | Kamiya Biomedical Co. | 2010-04-29 |
| TINA-QUANT CERULOPLASMIN (K091741) | Roche Diagnostics | 2010-03-18 |
| ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, (K093957) | Fujirebio Diagnostics,Inc. | 2010-03-18 |
| HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS (K092181) | Instrumentation Laboratory CO | 2010-03-11 |
| IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA (K091520) | Immco Diagnostics, Inc. | 2010-03-10 |
| THERATEST EL-ANTI-CCP/2 (K090753) | Theratest Laboratories, Inc. | 2010-03-05 |
| HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS (K082823) | The Binding Site Group , Ltd. | 2010-03-01 |
| AESKULISA MPO, MODEL 30-7303US (K091860) | Aesku Diagnostics | 2010-02-23 |
| IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA (K091522) | Immco Diagnostics, Inc. | 2010-02-04 |
| QUANTA LITE APS/PT IGG AND IGM ELISA (K090755) | Inova Diagnostics, Inc. | 2010-02-01 |
| IMMUNOCAP RAPID READER, MODEL 12-3600-10 (K092978) | Phadia US, Inc. | 2010-01-19 |
| PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM (K091052) | Abaxis, Inc. | 2010-01-15 |
| HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P) (K090920) | The Binding Site, Ltd. | 2009-12-30 |
| HUMAN IGD KIT FOR USE ON SPAPLUS (K092450) | The Binding Site | 2009-12-28 |
| XTAG CF60 KIT V2 (K083845) | Luminex Molecular Diagnostics, Inc. | 2009-12-11 |
| BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 (K092505) | Beckman Coulter, Inc. | 2009-12-11 |
| MODIFICATION TO MAMMAPRINT (K081092) | Agendia | 2009-12-11 |
| IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01 (K092050) | Phadia AB | 2009-11-20 |
| IVD TECHNOLOGIES ACHRAB TEST KIT (K091468) | Ivd Technologies | 2009-11-20 |
| IMMUNOSCAN CCPLUS (K091657) | Euro-Diagnostica AB | 2009-11-19 |
| IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM (K083080) | Sqi Diagnostics Systems | 2009-10-29 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 (K091984) | Siemens Medical Solutions Diagnostics | 2009-10-28 |
| DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG (K092283) | Siemens Healthcare Diagnostics | 2009-10-21 |
| ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN (K083260) | Roche Diagnostics | 2009-10-16 |
| THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR (K092757) | Thera-Test Laboratories, Inc. | 2009-10-09 |
| ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 (K083868) | Axis-Shield Diagnostics, Ltd. | 2009-09-25 |
| KAPPA LIGHT CHAINS (K083602) | SENTINEL CH. SpA | 2009-09-03 |
| THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120 (K090760) | Theratest Laboratories, Inc. | 2009-09-03 |
| XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 (K083846) | Luminex Molecular Diagnostics, Inc. | 2009-09-01 |
| EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG) (K083053) | Euroimmun Us, Inc. | 2009-08-07 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K091289) | Siemens Healthcare Diagnostics | 2009-08-06 |
| EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) (K083052) | Euroimmun Us, Inc. | 2009-07-28 |
| VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST (K083294) | Nanosphere, Inc. | 2009-07-24 |
| ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8 (K090901) | Osmetech Molecular Diagnostics | 2009-07-06 |
| LAMBDA LIGHT CHAINS (K083601) | SENTINEL CH. SpA | 2009-06-22 |
| VIDAS CA 15-3 ASSAY (K080469) | bioMerieux, Inc. | 2009-06-22 |
| ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01 (K083117) | Phadia US, Inc. | 2009-05-28 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K090257) | Siemens Healthcare Diagnostics | 2009-05-26 |
| THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY (K083391) | Diagnostic Hybrids, Inc. | 2009-05-21 |
| EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS (K083850) | Euroimmun Us, Inc. | 2009-05-20 |
| HUMAN BETA-2 MICROGLOBULIN KIT (K083289) | The Binding Site, Ltd. | 2009-05-06 |
| DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID (K090594) | Siemens Healthcare Diagnostics | 2009-04-29 |
| DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 (K090236) | Siemens Healthcare Diagnostics | 2009-04-27 |
| CAPILLARYS IMMUNOTYPING, MODEL 2100 (K082085) | Sebia | 2009-04-17 |
| EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) (K083381) | Euroimmun Us, Inc. | 2009-04-15 |
| MINICAP IMMUNOTYPING, MODEL: 2300 (K082388) | Sebia | 2009-04-14 |
| VIDAS CA 125 II ASSAY (K080561) | bioMerieux, Inc. | 2009-04-10 |
| ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY (K082759) | Phadia US, Inc. | 2009-04-10 |
| SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 (K082251) | Beckman Coulter, Inc. | 2009-04-08 |
| EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG) (K082130) | Euroimmun Us, Inc. | 2009-04-07 |
| N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC (K083445) | Siemens Healthcare Diagnostics | 2009-03-24 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K083853) | Siemens Healthcare Diagnostics | 2009-03-24 |
| C-REACTIVE PROTEIN (LATEX) (K083444) | Roche Diagnostics Corp. | 2009-03-18 |