| BBL CHROMAGAR 0157 (K070691) | Becton, Dickinson & CO | 2007-11-20 |
| VITEK 2 GRAM POSITIVE TIGECYCLINE (K072695) | bioMerieux, Inc. | 2007-11-16 |
| TRU FLU (K071657) | Meridian Bioscience, Inc. | 2007-11-15 |
| DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000 (K070265) | Diagnostic Hybrids, Inc. | 2007-10-24 |
| TRU RSV (K071101) | Meridian Bioscience, Inc. | 2007-10-18 |
| VITEK 2 GRAM POSITIVE VANCOMYCIN (K072668) | bioMerieux, Inc. | 2007-10-15 |
| VIDAS B.R.A.H.M.S. PCT ASSAY (K071146) | bioMerieux, Inc. | 2007-10-11 |
| PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G (K071511) | Focus Diagnostics, Inc. | 2007-10-05 |
| MODIFICATION TO BIOSTAR OIA SHIGATOX (K071799) | Iverness Medical Professional Diagnostics | 2007-10-02 |
| DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT (K063675) | Diagnostic Hybrids, Inc. | 2007-09-24 |
| HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950 (K071510) | Focus Diagnostics, Inc. | 2007-09-24 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML (K070809) | Becton, Dickinson & CO | 2007-09-24 |
| DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000 (K063798) | Diagnostic Hybrids, Inc. | 2007-09-21 |
| MRSASELECT (K070361) | Bio-Rad | 2007-09-13 |
| VITEK 2 GRAM NEGATIVE LEVOFLOXACIN (K072038) | bioMerieux, Inc. | 2007-09-12 |
| DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 (K070206) | Diagnostic Hybrids, Inc. | 2007-08-30 |
| MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN (K071317) | Dade Behring, Inc. | 2007-08-20 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, AMPICILLIN-SULBACTAM (GN) 1/0.5-32/16 UG/ML (K071623) | Becton, Dickinson & CO | 2007-08-20 |
| MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN (K071316) | Dade Behring, Inc. | 2007-08-20 |
| COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE (K070062) | Diesse Diagnostica Senese S.P.A. | 2007-07-30 |
| DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM (K070346) | Dade Behring, Inc. | 2007-07-18 |
| ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM (K070317) | Zeus Scientific, Inc. | 2007-07-05 |
| EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT (K061239) | Euroimmun Us, LLC | 2007-06-28 |
| SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST (K061496) | Sa Scientific , Ltd. | 2007-06-28 |
| MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE (K071268) | Dade Behring, Inc. | 2007-06-26 |
| BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX (DEN070006) | Inverness Medical Professional Diagnostics-Binax | 2007-06-13 |
| MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM (K071188) | Idaho Technology, Inc. | 2007-05-21 |
| SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS (K071076) | Dade Behring, Inc. | 2007-05-21 |
| MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CLINDAMYCIN (K070860) | Dade Behring, Inc. | 2007-05-11 |
| MONOLISA ANTI-HAV EIA (K063318) | Bio-Rad Laboratories | 2007-05-03 |
| MONOLISA ANTI-HAV IGM EIA (K063319) | Bio-Rad Laboratories | 2007-05-03 |
| QUICK VUE RSV TEST, MODELS 20193, 20199 (K070747) | Quidel Corp. | 2007-04-23 |
| XPERT MRSA (K070462) | Cepheid | 2007-04-17 |
| AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE (K070172) | Roche Diagnostics Corporation | 2007-04-17 |
| ABBOTT ARCHITECT HAVAB-M (K063329) | Abbott Laboratories | 2007-04-16 |
| AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY (K070174) | Roche Diagnostics Corporation | 2007-04-16 |
| LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871 (K062473) | DiaSorin, Inc. | 2007-04-12 |
| ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM (K063186) | Zeus Scientific, Inc. | 2007-03-21 |
| BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K063866) | Bio-Rad Laboratories | 2007-03-19 |
| XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065 (DEN070004) | Cepheid | 2007-03-16 |
| MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 (K070522) | Inverness Medical Professional Diagnostics | 2007-03-15 |
| ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K070262) | Oxoid , Ltd. | 2007-03-14 |
| BD DIRECTIGEN EZ FLU A+B TEST (K063689) | Becton, Dickinson & CO | 2007-03-07 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY (K063486) | Becton, Dickinson & CO | 2007-03-07 |
| DIASORIN LIAISON VZV IGG (K061820) | DiaSorin, Inc. | 2007-02-26 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM (GN) 0.5-64UG/ML (K063824) | Becton, Dickinson & CO | 2007-02-14 |
| IMMUNOCARD STAT! EHEC, MODEL 751630 (K062546) | Meridian Bioscience, Inc. | 2007-02-14 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/ML (K063811) | Becton, Dickinson & CO | 2007-02-09 |
| MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CHLORAMPHENICOL (4-16 UG/ML) (K063564) | Dade Behring, Inc. | 2007-02-08 |
| HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G (K062543) | Focus Diagnostics, Inc. | 2007-02-01 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFPODOXIME (GN) 0.125-8UG/ML (K063300) | Becton, Dickinson & CO | 2007-01-29 |
| GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 (K063664) | Gen-Probe, Inc. | 2007-01-25 |
| GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 (K063451) | Gen-Probe, Inc. | 2007-01-22 |
| VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE (K063597) | bioMerieux, Inc. | 2007-01-19 |
| VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE (K063623) | bioMerieux, Inc. | 2007-01-11 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTAZIDIME (GN) 0.5-64 UG/ML (K063573) | Becton, Dickinson & CO | 2007-01-11 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS (K063143) | Ortho-Clinical Diagnostics, Inc. | 2006-12-26 |
| GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL (K063224) | Gentris Corporation | 2006-12-22 |
| ENTEROCOCCUS FAECALIS PNA FISH (K063127) | Advandx, Inc. | 2006-12-22 |
| VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE (K063492) | bioMerieux, Inc. | 2006-12-21 |
| SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES (K062841) | Trek Diagnostic Systems, Inc. | 2006-12-20 |
| BIOSTAR OIA SHIGATOX (K061889) | Inverness Medical-Biostar, Inc. | 2006-12-12 |
| BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K062211) | Bio-Rad Laboratories, Inc. | 2006-12-08 |
| SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE (K063365) | Dade Behring, Inc. | 2006-12-08 |
| SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B (K062948) | Cepheid | 2006-12-08 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/ML (K063301) | Becton, Dickinson & CO | 2006-12-08 |
| MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE (K063366) | Dade Behring, Inc. | 2006-12-08 |
| BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K062213) | Bio-Rad Laboratories, Inc. | 2006-12-08 |
| SPECTRAL WEST NILE VIRUS IGM STATUS TEST (K052519) | Spectral Diagnostics, Inc. | 2006-11-30 |
| MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN (K063299) | Dade Behring, Inc. | 2006-11-27 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML (K062945) | Becton, Dickinson & CO | 2006-11-21 |
| MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN (2 - 256 UG/ML (K062938) | Dade Behring, Inc. | 2006-11-20 |
| D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT (K061101) | Diagnostic Hybrids, Inc. | 2006-11-20 |
| RAPIRUN H. PYLORI ANTIBODY DETECTION KIT (K052716) | Otsuka Pharmaceutical Co., Ltd. | 2006-11-16 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/ML (K062944) | Becton, Dickinson & CO | 2006-11-15 |
| BINAXNOW INFLUENZA A & B TEST (K062109) | Binax, Inc. | 2006-11-09 |
| MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K062839) | Trek Diagnostic Systems, Inc. | 2006-11-09 |
| MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) (K063102) | Dade Behring, Inc. | 2006-11-09 |
| GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 (K062440) | Gen-Probe, Inc. | 2006-11-07 |
| MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML) (K063099) | Dade Behring, Inc. | 2006-11-01 |
| SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K062816) | Trek Diagnostic Systems, Inc. | 2006-11-01 |
| MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML (K063101) | Dade Behring, Inc. | 2006-11-01 |
| MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML) (K063065) | Dade Behring, Inc. | 2006-10-27 |
| MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) (K063053) | Dade Behring, Inc. | 2006-10-26 |
| MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML) (K063064) | Dade Behring, Inc. | 2006-10-26 |
| MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML) (K062375) | Dade Behring, Inc. | 2006-10-26 |
| SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K062783) | Trek Diagnostic Systems, Inc. | 2006-10-26 |
| C. ALBICANS PNA FISH (K062461) | Advandx, Inc. | 2006-10-25 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANATE (GN) 1/2 - 128/2UG/ML (K062687) | Becton, Dickinson & CO | 2006-10-24 |
| SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K062722) | Trek Diagnostic Systems, Inc. | 2006-10-20 |
| SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID (K062705) | Dade Behring, Inc. | 2006-10-20 |
| LIAISON EA IGG (K060204) | DiaSorin, Inc. | 2006-10-18 |
| MASTALEX -MRSA, MODEL RST501 (K062864) | Mast Group , Ltd. | 2006-10-18 |
| SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K062681) | Trek Diagnostic Systems, Ltd. | 2006-10-13 |
| MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN (K062773) | Dade Behring, Inc. | 2006-10-13 |
| MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML) (K062923) | Dade Behring, Inc. | 2006-10-13 |
| APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM (K061413) | Gen-Probe, Inc. | 2006-10-13 |
| INTROL CF PANEL I CONTROL (DEN060007) | Maine Molecular Quality Controls, Inc. | 2006-10-12 |
| MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML) (K062927) | Dade Behring, Inc. | 2006-10-12 |
| MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN (K062777) | Dade Behring, Inc. | 2006-10-10 |