| BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV (K132456) | Becton, Dickinson and Company | 2013-11-07 |
| PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM (K131630) | Puritan Medical Products, LLC | 2013-10-21 |
| MRSA/SA ELITE MGB, ELITE MGB SOFTWARE (K132468) | Elitechgroup Epoch Biosciences | 2013-10-17 |
| APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) (K132251) | Hologic / Gen-Probe Incorporated | 2013-10-17 |
| IMDX C.DIFFICILE FOR ABBOTT M2000 (K132235) | Intelligent Medical Devices, Inc. | 2013-10-11 |
| VITEK 2 AST-ST TIGECYCLINE (K131779) | bioMerieux, Inc. | 2013-10-10 |
| VIDAS C DIFFICILE GDH (K132010) | Biomerieux S.A. | 2013-10-09 |
| BD Veritorâ„¢ System Flu A+B Assay (K132693) | Becton, Dickinson and Company | 2013-10-02 |
| BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B (K132692) | Becton, Dickinson and Company | 2013-09-23 |
| CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K132508) | Centers for Disease Control and Prevention | 2013-09-23 |
| VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN (K132573) | bioMerieux, Inc. | 2013-09-13 |
| BIOSIGN FLU A + B, STATUS FLU A & B (K132465) | Princeton BioMeditech Corp. | 2013-09-09 |
| QUIDEL MOLECULAR RSV + HMPV ASSAY (K131813) | Quidel Corp. | 2013-09-06 |
| QUIDEL MOLECULAR INFLUENZA A + B ASSAY (K131728) | Quidel Corp. | 2013-08-29 |
| LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II (K132234) | DiaSorin, Inc. | 2013-08-28 |
| PROPARAFLU+ ASSAY (K132238) | Gen-Probe Prodesse, Inc. | 2013-08-26 |
| PRODESSE PROFAST+ ASSAY (K132237) | Gen-Probe Prodesse, Inc. | 2013-08-26 |
| SAS FLUALERT A & B, SAS INFLUENZA A TEST (K132352) | Sa Scientific , Ltd. | 2013-08-22 |
| IMDX FLU A/B AND RSV FOR ABBOTT M2000 (K131584) | Intelligent Medical Devices, Inc. | 2013-08-21 |
| VITEK MS (DEN130013) | bioMerieux, Inc. | 2013-08-21 |
| PRO HMPV+ ASSAY (K132200) | Gen-Probe Prodesse, Inc. | 2013-08-14 |
| PROADENO+ ASSAY (K132159) | Gen-Probe Prodesse, Inc. | 2013-08-14 |
| SOFIA(R) RSV FIA (K130398) | Quidel Corp. | 2013-08-13 |
| PRODESSE PROFLU+ ASSAY (K132129) | Gen-Probe Prodesse, Inc. | 2013-08-09 |
| LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II (K131441) | DiaSorin, Inc. | 2013-08-09 |
| BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B (K132256) | Becton, Dickinson and Company | 2013-08-07 |
| BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B (K132259) | Becton, Dickinson and Company | 2013-08-07 |
| JBAIDS ANTHRAX DETECTION KIT (K131930) | Biofire Diagnostics, Inc. | 2013-08-05 |
| JBAIDS TULAREMIA DETECTION KIT (K131936) | Biofire Diagnostics, Inc. | 2013-07-31 |
| XPERT MTB/RIF ASSAY (DEN130032) | Cepheid | 2013-07-25 |
| GRAM-NEGATIVE QUICKFISH BC (K123418) | Advandx, Inc. | 2013-07-21 |
| IMDX VANR FOR ABBOTT M2000 (K123753) | Intelligent Medical Devices, Inc. | 2013-07-17 |
| REMEL XPECT FLU A&B (K131804) | Remel, Inc. | 2013-07-12 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML) (K131331) | Becton, Dickinson & CO | 2013-07-10 |
| QUICK VUE INFLUENZA (K131599) | Quidel Corporation | 2013-07-05 |
| SOFIA INFLUENZA A+B FIA (K131606) | Quidel Corp. | 2013-07-05 |
| QUICKVUE INFLUENZA A+B (K131619) | Quidel Corp. | 2013-06-28 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML) (K123404) | Becton, Dickinson & CO | 2013-06-27 |
| BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN (K123266) | Becton, Dickinson and Company | 2013-06-26 |
| FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL (K130914) | Biofire Diagnostics, Inc. | 2013-06-21 |
| XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE (K130894) | Cepheid | 2013-06-20 |
| SOFIA STREP A FIA (K123793) | Quidel Corporation | 2013-06-17 |
| ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT (K123423) | Meridian Bioscience, Inc. | 2013-06-05 |
| VIDAS LYME IGM (K122979) | Biomerieux S.A. | 2013-06-04 |
| BREATHID HP SYSTEM (K130524) | Exalenz Bioscience , Ltd. | 2013-05-22 |
| CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K130551) | Centers for Disease Control and Prevention | 2013-05-22 |
| BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) (K123903) | Becton, Dickinson & CO | 2013-05-13 |
| BD MAX CDIFF ASSAY, BD MAX INSTRUMENT (K130470) | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2013-04-02 |
| XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX (K121894) | Luminex Molecular Diagnostics, Inc. | 2013-03-21 |
| MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE (K123933) | Siemens Healthcare Diagnostics, Inc. | 2013-03-14 |
| QUIDEL MOLECULAR RSV + HMPV ASSAY (K122189) | Quidel Corp. | 2013-03-08 |
| QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY (K123998) | Quidel Corp. | 2013-03-08 |
| VIDAS LYME IGG (K122986) | Biomerieux S.A. | 2013-03-05 |
| UNIGOLD GIARDIA (K120001) | Trinity Biotech | 2013-03-01 |
| FILMARRAY RESPIRATORY PANEL (RP) (K123620) | Biofire Diagnostics, Inc. | 2013-02-11 |
| ADENOVIRUS R-GENE US (K121942) | Argene SA | 2013-02-08 |
| UNI-GOLD CRYPTOSPORIDIUM (K121565) | Trinity Biotech | 2013-02-08 |
| BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP (K122718) | Becton, Dickinson and Company | 2013-02-06 |
| BACT/ALERT FN PLUS CULTURE BOTTLE (K121455) | bioMerieux, Inc. | 2013-01-25 |
| BACT/ALERT PF PLUS CULTURE BOTTLE (K121446) | bioMerieux, Inc. | 2013-01-25 |
| BACT/ALERT FA PLUS CULTURE BOTTLE (K121461) | bioMerieux, Inc. | 2013-01-22 |
| PROGASTRO SSCS ASSAY (K123274) | Gen-Probe Prodesse, Inc. | 2013-01-16 |
| PRO HMPV+ ASSAY (K123838) | Gen-Probe Prodesse, Inc. | 2013-01-16 |
| CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K123905) | Centers for Disease Control and Prevention | 2013-01-14 |
| XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS) (DEN130003) | Luminex Molecular Diagnostics, Inc. | 2013-01-14 |
| ENTEROCOCCUS QUICKFISH BC (K121991) | Advandx, Inc. | 2013-01-07 |
| XPERT CT/NG (K121710) | Cepheid | 2012-12-27 |
| XPERT FLU (K123191) | Cepheid | 2012-12-21 |
| ABBOTT PLEX-ID FLU ASSAY (K121003) | Abbott Laboratories | 2012-12-21 |
| ALPHA CRYPTOCOCCAL ANTIGEN EIA (K120946) | Immuno-Mycologics, Inc. | 2012-12-17 |
| AMPLIVUE C. DIFFICILE ASSAY (K123355) | Quidel Corporation | 2012-12-13 |
| VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) (K123197) | Nanosphere, Inc. | 2012-12-05 |
| VITEK 2 GRAM NEGATIVE DOXYCYCLINE (K121546) | bioMerieux, Inc. | 2012-11-20 |
| VITEK 2 AST STREPTOCOCUS VANCOMYCIN (K121100) | bioMerieux, Inc. | 2012-11-19 |
| VRESELECT CULTURE MEDIUM (K122187) | Bio-Rad | 2012-11-06 |
| OSOM INFLUENZA A&B TEST MODEL 190 (K123182) | SEKISUI Diagnostics, LLC | 2012-11-05 |
| XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX) (K121539) | Cepheid | 2012-11-02 |
| BIOPLEX 2200 EBV IGM KIT (K123021) | Bio-Rad Laboratories | 2012-11-02 |
| GRAM POSTITVE CLINDAMYCIN (K122547) | bioMerieux, Inc. | 2012-10-15 |
| ETEST CEFTAROLINE (K121002) | bioMerieux, Inc. | 2012-10-12 |
| SHIGA TOXIN CHEK (K121411) | Techlab Inc., Corporate Research Center | 2012-10-02 |
| SHIGA TOXIN QUIK CHEK (K121364) | Techlab Inc., Corporate Research Center | 2012-10-02 |
| VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST (K122514) | Nanosphere, Inc. | 2012-09-19 |
| BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV (K121633) | Becton, Dickinson and Company | 2012-09-18 |
| STREPTOCOCCUS APP. SEROLOGICAL REAGENTS (K122019) | Meridian Bioscience, Inc. | 2012-09-13 |
| BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B (K121797) | Becton, Dickinson and Company | 2012-09-07 |
| LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM (K122397) | DiaSorin, Inc. | 2012-09-06 |
| VITEK 2 STRPTOCOCCUS CEFTRIAXONE (K122359) | bioMerieux, Inc. | 2012-08-28 |
| STRATIFY JCV DXSELECT (K120986) | Focus Diagnostics, Inc. | 2012-08-16 |
| VITEK 2 AST-ST CEFOTAXIME (K121863) | bioMerieux, Inc. | 2012-08-16 |
| BD BACTEC Plus PRIME Aerobic/F Culture Vials (K120994) | Becton, Dickinson and Company | 2012-08-07 |
| VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE (K113783) | bioMerieux, Inc. | 2012-08-07 |
| ALERE PBP2A TEST (K121905) | Alere Scarborough, Inc. | 2012-07-26 |
| ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM (K113397) | Zeus Scientific, Inc. | 2012-07-26 |
| ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV (K120625) | Roche Diagnostics | 2012-07-25 |
| SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK (K120413) | Focus Diagnostics, Inc. | 2012-07-13 |
| BD MAX MRSA ASSAY, BD MAX INSTRUMENT (K120138) | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2012-07-05 |
| VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM (K113200) | bioMerieux, Inc. | 2012-06-29 |
| ARCHITECT HAVAB-G (K113704) | Abbott Laboratories | 2012-06-28 |
| VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) (DEN120014) | Nanosphere, Inc. | 2012-06-26 |