| Para-Fix C&S Medium (K150887) | Medical Chemical Corporation | 2015-05-29 |
| cobas Cdiff Test (K142422) | Roche Molecular Systems, Inc. | 2015-05-20 |
| EUROIMMUN LYME ELISA(IgG/IgM) (K142038) | Euroimmun US | 2015-05-04 |
| Portrait GBS Assay (K143312) | Great Basin Corporation | 2015-04-21 |
| GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC (K143592) | The Surgeon General, Department of the Army | 2015-04-16 |
| COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM (K142094) | Copan Italia Spa | 2015-04-10 |
| Sensititre Susceptibility plates (K143288) | Thermo Fisher Scientific | 2015-04-01 |
| ALERE I STREP A (K141757) | Alere Scarborough, Inc. | 2015-03-31 |
| MALDI Biotyper CA System (K142677) | Bruker Daltonics, Inc. | 2015-03-27 |
| Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack (K143651) | Focus Diagnostics, Inc. | 2015-03-18 |
| LIAISON VZV IgG, LIAISON Control VZV IgG (K150375) | DiaSorin, Inc. | 2015-03-11 |
| The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml) (K143526) | Thermo Fisher Scientific | 2015-03-05 |
| Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml) (K142338) | Thermo Fisher Scientific | 2015-03-02 |
| MCC Para-Fix CARY BLAIR MEDIUM (K141506) | Medical Chemical Corporation | 2015-02-25 |
| FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 (K143005) | Biofire Diagnostics, LLC | 2015-02-19 |
| Sensititre Susceptibility Plates (K143381) | Thermo Fisher Scientific | 2015-02-19 |
| FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System (K143080) | Biofire Diagnostics, LLC | 2015-02-17 |
| SEEGENE ANYPLEX II HSV-1/2 ASSAY (K142156) | Seegene | 2015-02-13 |
| Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 (K143302) | Cepheid | 2015-02-12 |
| FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 (K143171) | Biofire Diagnostics, LLC | 2015-01-30 |
| Puritan OptiTranz Liquid Stuart Collection and Transport System (K142366) | Puritan Medical Products, LLC | 2015-01-09 |
| SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES (K142151) | Thermo Fisher Scientific | 2014-12-23 |
| artus HSV-1/2 QS-RGQ MDx Kit (K142738) | Qiagen | 2014-12-19 |
| cobas MRSA/SA Test (K142721) | Roche Molecular Systems, Inc. | 2014-12-17 |
| SOFIA (R) STREP A+ FIA (K141775) | Quidel Corporation | 2014-12-16 |
| AmpliVue Bordetella Assay (K143206) | Quidel Corporation | 2014-12-10 |
| BD BACTEC PLUS ANAEROBIC/F (PLASTIC) (K141810) | Becton, Dickinson and Company | 2014-12-10 |
| ADVIA Centaur HAV total assay (K142758) | Siemens Healthcare Diagnostics, Inc. | 2014-12-05 |
| Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack (K142365) | Focus Diagnostics | 2014-12-05 |
| Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System (K142501) | Cepheid | 2014-11-26 |
| XPERT FLU/RSV XC ASSAY (K142045) | Cepheid | 2014-11-22 |
| CL DETECT RAPID TEST (K141341) | InBios International, Inc. | 2014-11-14 |
| LIAT STREP A ASSAY (K141338) | Iquum, Inc. | 2014-11-04 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP (K142170) | Becton, Dickinson and Company | 2014-10-28 |
| ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM (K142133) | Roche Diagnostics | 2014-10-24 |
| XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP) (K140647) | Luminex Molecular Diagnostics, Inc. | 2014-10-24 |
| SENSITITRE SUSCEPTIBILITY PLATES (K141651) | Thermo Fisher Scientific | 2014-10-21 |
| VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP) (K142033) | Nanospere,Inc. | 2014-10-10 |
| MECA XPRESSFISH (K140619) | Advandx, Inc. | 2014-10-10 |
| LYRA PARAINFLUENZA VIRUS ASSAY (K141927) | Quidel Corporation | 2014-10-09 |
| LYRA ADENOVIRUS ASSAY (K141931) | Quidel Corporation | 2014-10-09 |
| T2CANDIDA AND T2DX INSTRUMENT (DEN140019) | T2biosystems, Inc. | 2014-09-22 |
| XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) (K140377) | Luminex Molecular Diagnostics, Inc. | 2014-09-16 |
| ALERE PBP2A SA/CONS CULTURE COLONY TEST (K133851) | Alere Scarborough, Inc. | 2014-09-03 |
| VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE (K133952) | bioMerieux, Inc. | 2014-08-19 |
| VITEK 2 AST - YEAST FLUCONAZOLE (K133817) | bioMerieux, Inc. | 2014-08-05 |
| CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING (K141859) | Centers for Disease Control and Prevention | 2014-08-01 |
| SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES (K133847) | Thermo Fisher Scientific | 2014-08-01 |
| LIAISON XL ANALYZER (K141116) | DiaSorin, Inc. | 2014-07-25 |
| AMPLIVUE GAS ASSAY (K141173) | Quidel Corporation | 2014-07-24 |
| SENSITITRE SUSCEPTIBILITY PLATES (K141000) | Thermo Fisher Scientific | 2014-07-16 |
| SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK (K141458) | Focus Diagnostics | 2014-07-01 |
| MUELLER HINTON AGAR (K132491) | Edge Biologicals, Inc. | 2014-06-30 |
| EUROIMMUN ANTI-PLA2R ELISA (IGG) (K132195) | Euroimmun Us, Inc. | 2014-06-27 |
| VITEK 2 AST GP CEFTAROLINE (K141149) | bioMerieux, Inc. | 2014-06-20 |
| VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) (K140083) | Nanosphere, Inc. | 2014-06-20 |
| ALERE I INFLUENZA A & B (K141520) | Alere Scarborough, Inc D/B/A Binax, Inc. | 2014-06-13 |
| SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES (K140985) | Thermo Fisher Scientific | 2014-06-10 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML) (K140468) | Becton, Dickinson and Company | 2014-06-02 |
| EUROIMMUN ANTI-PLA2R IFA (DEN140002) | Euroimmun US | 2014-05-29 |
| CAPTIA MEASLES IGM (K140455) | Trinity Biotech USA | 2014-05-22 |
| ANTHRACIS REAL-TIME PCR ASSAY (K140426) | Centers For Disease Control and Prevention (CDC) | 2014-05-22 |
| BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY (K140448) | Becton, Dickinson & CO | 2014-05-20 |
| BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY (K140446) | Becton, Dickinson & CO | 2014-05-20 |
| QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY (DEN140004) | Diagnostic Hybrids, Inc. | 2014-05-13 |
| IMDX HSV-1/2 FOR ABBOTT M2000 (K140198) | Intelligent Medical Devices, Inc. | 2014-05-13 |
| ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG (K140354) | Abbott Molecular, Inc. | 2014-05-09 |
| BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT (K140111) | Becton, Dickinson and Company | 2014-05-06 |
| COBAS CT/NG V2.0 TEST (K140887) | Roche Molecular Systems, Inc. | 2014-05-05 |
| FILMARRAY GASTROINTESTINAL (GI) PANEL (K140407) | Biofire Diagnostics | 2014-05-02 |
| INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K140857) | Centers for Disease Control and Prevention | 2014-04-25 |
| INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K140851) | Centers for Disease Control and Prevention | 2014-04-25 |
| LYRA DIRECT STREP ASSAY (DEN140005) | Quidel Corporation | 2014-04-16 |
| ARTUS C. DIFFICILE QS-RGQ MDX KIT (K133936) | QIAGEN GmbH | 2014-04-04 |
| AMIPLIVUE HSV 1&2 ASSAY (K140029) | Quidel Corporation | 2014-03-26 |
| ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA (K133673) | Meridian Bioscience, Inc. | 2014-03-25 |
| SIMPLEXA HSV 1&2 DIRECT (DEN130049) | Focus Diagnostics | 2014-03-21 |
| HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST (K131334) | Gold Standard Diagnostics | 2014-02-28 |
| ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY (K131605) | Roche Diagnostics | 2014-02-28 |
| SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM (K133773) | Thermo Fisher Scientific | 2014-02-27 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML) (K132909) | Becton, Dickinson and Company | 2014-02-14 |
| SENSITITRE YEASTONE SUSCEPTIBILITY PLATES (K133038) | Trek Diagnostic Systems | 2014-01-31 |
| WONDFO RAPID STREP A TEST (K133343) | Guangzhou Wondfo Biotech Co., Ltd. | 2014-01-31 |
| CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT (K133869) | Center For Disease Control and Prevention (Cdc) | 2014-01-17 |
| VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) (K132843) | Nanosphere, Inc. | 2014-01-08 |
| TRU FLU (K133714) | Meridian Bioscience, Inc. | 2014-01-03 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML) (K132674) | Becton, Dickinson and Company | 2013-12-27 |
| AMPLIVUE GBS ASSAY (K133503) | Quidel Corporation | 2013-12-20 |
| BD MAX MRSA XT, BD MAX INSTRUMENT (K133605) | Geneohm Sciences Canada, Inc. | 2013-12-20 |
| ALERE INFLUENZA A & B TEST (K133637) | Alere Scarborough, Inc D/B/A Binax, Inc. | 2013-12-18 |
| BIOSIGN FLU A + B, STATUS FLU A & B (K133474) | Princeton BioMeditech Corp. | 2013-12-10 |
| ALERE BINAXNOW INFLUENZA A & B CARD (K133411) | Alere Scarborough, Inc D/B/A Binax, Inc. | 2013-12-05 |
| COBAS CT/NG V2.0 TEST (K132270) | Roche Molecular Systems, Inc. | 2013-12-02 |
| ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM (K132726) | Primeradx | 2013-11-29 |
| BD MAX STAPHSR ASSAY, INSTRUMENT (K132822) | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2013-11-26 |
| MALDI BIOTYPER CA (MBT-CA) SYSTEM (K130831) | Bruker Daltonics, Inc. | 2013-11-21 |
| BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV (K133140) | Becton, Dickinson & CO | 2013-11-15 |
| VITEK 2 AST ST MEROPENEM (K132507) | bioMerieux, Inc. | 2013-11-15 |
| BD Veritorâ„¢ System Flu A+B Assay (K133138) | Becton, Dickinson & CO | 2013-11-13 |
| MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS (K131275) | Siemens Helathcare Diagnostics, Inc. | 2013-11-08 |