| BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT (K120959) | Bio-Rad Laboratories | 2012-06-22 |
| TRANSPORT CULTURE MEDIUM DEVICE (K120846) | Puritan Medical Products, LLC | 2012-06-08 |
| BORRELIA BURGDORFERI IGM BLOT TEST (K113846) | Gold Standard Diagnostics | 2012-06-01 |
| MRSA/SA ELITE MGB (K112937) | Elitech | 2012-06-01 |
| COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM (K121039) | Copan Flock Technologies | 2012-05-25 |
| CDC DENV-1-4 REAL TIME RT-PCT ASSAY (DEN120012) | Centers for Disease Control and Prevention | 2012-05-24 |
| XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV) (K120911) | Cepheid | 2012-05-18 |
| FILMARRAY RP PANEL (K120267) | Idaho Technology, Inc. | 2012-05-15 |
| APTIMA COMBO 2 ASSAY (K111409) | Gen-Probe, Inc. | 2012-05-03 |
| ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM (K121044) | Meridian Bioscience, Inc. | 2012-05-01 |
| PORTRAIT ANALYZER (DEN120013) | Great Basin Scientific | 2012-04-30 |
| BORRELIA BURGDORFERI IGG BLOT TEST (K113847) | Gold Standard Diagnostics | 2012-04-11 |
| SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT (K113433) | Focus Diagnostics, Inc. | 2012-04-04 |
| STAPHYLOCOCCUS QUICKFISH BC (K113371) | Advandx, Inc. | 2012-04-03 |
| KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT (K120563) | Microphage, Inc. | 2012-03-30 |
| CRAG LATERAL FLOW ASSAY (LFA) (K112422) | Immuno-Mycologics, Inc. | 2012-03-28 |
| BIOPLEX 2200 TORC IGG (K120572) | Bio-Rad Laboratories, Inc. | 2012-03-26 |
| BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B (K120049) | Becton, Dickinson and Company | 2012-03-23 |
| BD BACTEC Plus Aerobic/F Culture Vials (plastic) (K113558) | Becton, Dickinson and Company | 2012-03-16 |
| QUIDEL MOLECULAR INFLUENZA A+B (K113777) | Quidel Corp. | 2012-03-15 |
| BIOPLEX 2200 EBV IGG AND SYPHILIS IGG (K120439) | Bio-Rad Laboratories, Inc. | 2012-03-14 |
| HELICOBACTER PYLORI ELISA IGG TEST KIT (K110745) | Gold Standard Diagnostics | 2012-03-02 |
| TRANSPORT CULTURE MEDIUM DEVICE (K113249) | Puritan Medical Products, LLC | 2012-03-01 |
| VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE (K111893) | bioMerieux, Inc. | 2012-02-28 |
| TRU LEGIONELLA (K113190) | Meridian Bioscience, Inc. | 2012-02-24 |
| VITEK 2 STREPTOCOCCUS ERYTHROMYCIN (K111976) | bioMerieux, Inc. | 2012-02-17 |
| TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I) (K112781) | Luminex Molecular Diagnostics, Inc. | 2012-02-17 |
| BD MAX GBS ASSAY, BD MAX INSTRUMENT (K111860) | Becton, Dickinson & CO | 2012-02-16 |
| VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE (K113305) | bioMerieux, Inc. | 2012-02-10 |
| ARTUS INFL A/B RG RT-PCR KIT (K113323) | QIAGEN GmbH | 2012-02-06 |
| GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT (K110899) | Gold Standard Diagnostics | 2012-02-01 |
| COBAS 4800 CT / NG TEST (K110923) | Roche Molecular Systems, Inc. | 2012-01-24 |
| STRATIFY JCV(TM) ANTIBODY (DEN120008) | Focus Diagnostics, Inc. | 2012-01-20 |
| TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS (K112343) | Siemens Healthcare Diagnostics, Inc. | 2012-01-20 |
| QUIDEL MOLECULAR INFLUENZA A + B ASSAY (K112172) | Quidel Corp. | 2011-12-22 |
| VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) (K112424) | Nanosphere, Inc. | 2011-12-16 |
| IMMUNOCARD C. DIFFICILE GDH (K112048) | Meridian Bioscience, Inc. | 2011-12-16 |
| QUIDEL MOLECULAR HMPV ASSAY (K112490) | Quidel Corp. | 2011-12-15 |
| ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT (K112125) | Meridian Bioscience, Inc. | 2011-12-05 |
| VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE (K110106) | bioMerieux, Inc. | 2011-11-30 |
| VIZION (K112276) | Trek Diagnostic Systems | 2011-11-16 |
| SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES (K111615) | Trek Diagnostic Systems | 2011-11-08 |
| BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B (K112277) | Becton, Dickinson and Company | 2011-10-28 |
| VITEK 2 STREPTOCOCCUS PENICILLIN (K112000) | bioMerieux, Inc. | 2011-10-26 |
| SOFIA ANALYZER AND INFLUENZA A+B FIA (K112177) | Quidel Corp. | 2011-10-24 |
| VRESELECT CULTURE MEDIUM (K103684) | Bio-Rad | 2011-10-21 |
| BD GENEOHM VANR ASSAY (K102416) | Bd Diagnostics Science | 2011-10-20 |
| CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) (K112586) | Becton, Dickinson and Company (BD) | 2011-10-18 |
| VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE (K111909) | bioMerieux, Inc. | 2011-10-18 |
| VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE (K103752) | bioMerieux, Inc. | 2011-10-14 |
| VITEK 2 STREPTOCOCCUS LEVOFLOXACIN (K112228) | bioMerieux, Inc. | 2011-10-03 |
| ISOAMP HSV ASSAY (K111951) | Biohelix Corporation | 2011-09-27 |
| VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN (K112129) | bioMerieux, Inc. | 2011-09-27 |
| SENSITITRE OPTIREAD (K110583) | Trek Diagnostic Systems, Ltd. | 2011-09-22 |
| VITEK 2 STRPTOCOCCUS AMPICILLIN (K112075) | bioMerieux, Inc. | 2011-09-15 |
| JBAIDS INFLUENZA A&B DETECTION KIT (K111775) | U.S. Army Medical Material Development Acitvity | 2011-09-13 |
| JBAIDS INFLUENZA A SUBTYPING KIT (K111778) | U.S Army Medical Materiel Development Activity | 2011-09-13 |
| XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1) (K112199) | Luminex Molecular Diagnostics, Inc. | 2011-09-01 |
| AUTOREADER 2 (K103532) | Trek Diagnostic Systems | 2011-08-26 |
| VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY (K101234) | Ventana Medical Systems, Inc. | 2011-08-25 |
| CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K111507) | Centers for Disease Control and Prevention | 2011-08-23 |
| BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL (K111072) | Bio-Rad Laboratories | 2011-08-23 |
| GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK (K103673) | Techlab Inc., Corporate Research Center | 2011-08-18 |
| SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... (K111429) | Trek Diagnostic Systems, Ltd. | 2011-08-18 |
| VITEK 2 AST-ST LINEZOLID (K111599) | bioMerieux, Inc. | 2011-08-12 |
| LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER (K111387) | Iquum, Inc. | 2011-08-04 |
| MICROSCAN(R) MICROSTREP PLUS(R) (K111677) | Siemens Healthcare Diagnostics, Inc. | 2011-08-04 |
| MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT (K111527) | Eragen Biosciences, Inc. | 2011-08-03 |
| SYPHILIS HEALTH CHECK (K102400) | Diagnostics Direct, LLC | 2011-08-01 |
| MICROSCAN (R) MICROSTREP PLUS (R) PANELS (K111205) | Siemens Healthcare Diagnostics, Inc. | 2011-07-20 |
| CRAG LATERAL FLOW ASSAY (CRAG LFA) (K102286) | Immuno-Mycologics, Inc. | 2011-07-20 |
| ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 (K101407) | Immuno-Mycologics, Inc. | 2011-07-19 |
| XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST (K103776) | Luminex Molecular Diagnostics, Inc. | 2011-07-01 |
| PROFLU+ ASSAY (K110968) | Gen-Probe Prodesse, Inc. | 2011-06-27 |
| THE SENSITITRE AIM (K103456) | Trek Diagnostic Systems | 2011-06-22 |
| MICROSCAN MICROSTEP (K111394) | Siemens Healthcare Diagnostics, Inc. | 2011-06-22 |
| SMART LEISH, MODEL LGM1-050 (K081868) | U.S. Army Medical Research Institute of Infectious | 2011-05-25 |
| JBAIDS Q FEVER DETECTION KIT (K103207) | Idaho Technology, Inc. | 2011-05-20 |
| ZEUS ELISA HSV GG-2 IGG TEST SYSTEM (K103603) | Zeus Scientific, Inc. | 2011-05-20 |
| NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6 (K102740) | bioMerieux, Inc. | 2011-05-20 |
| VIDAS TOXO IGG AVIDITY (K101946) | bioMerieux, Inc. | 2011-05-18 |
| RPS ADENO DETECTOR PLUS (K110722) | Rapid Pathogen Screening, Inc. | 2011-05-17 |
| ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML (K102535) | Biomerieux S.A. | 2011-05-16 |
| KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT (K102342) | Microphage, Inc. | 2011-05-05 |
| ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) (K102681) | Siemens Healthcare Diagnostics, Inc. | 2011-05-04 |
| HARDYCHROM MRSA (K102922) | Hardy Diagnostics | 2011-05-04 |
| PREMIER C. DIFFICILE GDH (K110620) | Meridian Bioscience, Inc. | 2011-05-03 |
| FILMARRAY RP PANEL (K110764) | Idaho Technology, Inc. | 2011-04-27 |
| SENSITITRE AIM (TM) (K110331) | Trek Diagnostic Systems, Ltd. | 2011-04-27 |
| ZEUS ELISA HSV GC-I IGG TEST SYSTEM (K103363) | Zeus Scientific, Inc. | 2011-04-26 |
| XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0 (K103766) | Cepheid | 2011-04-21 |
| DENV DETECT IGM CAPTURE ELISA (DEN100020) | Inbios Intl., Inc. | 2011-04-08 |
| XPERT C. DIFFICLE/EPI ASSAY (K110203) | Cepheid | 2011-04-07 |
| BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS (K103798) | Becton, Dickinson & CO | 2011-03-18 |
| ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 (K110012) | Meridian Bioscience, Inc. | 2011-02-24 |
| RIDASCREEN NOROVIRUS 3RD GENERATION EIA (DEN110001) | R-Biopharm AG | 2011-02-23 |
| FILMARRAY RESPIRATORY PANEL (RP) (K103175) | Idaho Technology, Inc. | 2011-02-17 |
| ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM (K102283) | Zeus Scientific, Inc. | 2011-02-10 |
| MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE (K103805) | Medical Wire & Equipment Company (Bath), Ltd. | 2011-01-25 |
| MAGO 4S (K093101) | Diamedix Corp. | 2011-01-21 |