| LIAISON XL ANALYZER MODEL 10050 (K103529) | DiaSorin, Inc. | 2011-01-21 |
| PLATELIA ASPERGILLUS EIA MODEL 62793 (K093678) | Bio-Rad | 2011-01-13 |
| VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+) (K103209) | Nanosphere, Inc. | 2011-01-10 |
| CLEARVIEW EXACT II INFLUENZA A & B TEST (K103610) | Alere Scarborough, Inc D/B/A Binax, Inc. | 2011-01-06 |
| OSOM C. DIFFICILE TOXIN A/B TEST (K102242) | Genzyme Corporation | 2010-12-21 |
| HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939 (K103538) | Hardy Diagnostics | 2010-12-17 |
| GNR TRAFFIC LIGHT PNA FISH (K101558) | Advandx, Inc. | 2010-12-16 |
| PRODESSE PROADENO (K102952) | Gen-Probe Prodesse, Inc. | 2010-12-03 |
| BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM (K092587) | Bio-Rad Laboratories | 2010-12-03 |
| SIMPLEXA FLU A/B & RSV (K102170) | Focus Diagnostics, Inc. | 2010-11-24 |
| ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML (K102668) | BIOMERIEUX | 2010-11-17 |
| BIOSIGN FLU A+B (K083746) | Princeton BioMeditech Corp. | 2010-11-10 |
| MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (K100589) | Bio-Rad | 2010-10-29 |
| VITEK 2 GRAM POSITIVE DOXCYCLINE (K093076) | bioMerieux, Inc. | 2010-10-21 |
| REMEL SPECTRA MRSA (K092407) | Remel, Inc. | 2010-10-08 |
| ANTI-HAV (K100903) | Roche Professional Diagnostics | 2010-10-05 |
| ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM (K093837) | Zeus Scientific, Inc. (Zeus) | 2010-10-01 |
| CRIT-LINE ANEMIA MANAGEMENT SOFTWARE (K093834) | Hema Metrics, LLC | 2010-09-29 |
| VITEK 2 YEAST CASPOFUNGIN (K101566) | bioMerieux, Inc. | 2010-09-28 |
| QUICKVUE RSV 10 (K101918) | Quidel Corp. | 2010-09-24 |
| MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES (K101425) | Siemens Healthcare Diagnostics | 2010-09-10 |
| ETEST MOXIFLOXACIN 0.002-32 UG/ML (K093604) | Ab Biomerieux | 2010-08-25 |
| BBL CHROMAGAR MRSA II (K092767) | Becton, Dickinson & CO | 2010-08-20 |
| XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10 (K101879) | Cepheid | 2010-07-28 |
| PROFAST+ ASSAY (K101855) | Gen-Probe Prodesse, Inc. | 2010-07-23 |
| ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM (K093784) | Zeus Scientific, Inc. | 2010-07-16 |
| YEAST TRAFFIC LIGHT PNA FISH (K093024) | Advandx, Inc. | 2010-07-15 |
| REMEL SPECTRA VRE (K092819) | Thermo Fisher Scientific | 2010-07-15 |
| ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920 (K100818) | Meridian Bioscience, Inc. | 2010-07-09 |
| BD DIRECTIGEN EZ RSV (K101514) | Becton, Dickinson & CO | 2010-07-09 |
| ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM (K100728) | Zeus Scientific, Inc. | 2010-07-06 |
| JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136 (K100287) | U.S. Army Medical Material Development Command | 2010-07-06 |
| LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727 (K091409) | Roche Molecular Systems, Inc. | 2010-07-06 |
| BD DIRECTIGEN EX FLU A+B (K101461) | Becton, Dickinson and Company | 2010-06-24 |
| CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL (K101564) | Centers for Disease Control and Prevention | 2010-06-22 |
| ANTI-HAV IGM (K093955) | Roche Diagnostics | 2010-06-22 |
| BD DIRECTIGEN EZ FLU A+B ASSAY (K101529) | Becton, Dickinson & CO | 2010-06-14 |
| XPERT MRSA/SA NASAL ASSAY (K100822) | Cepheid | 2010-06-01 |
| ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03 (K092704) | Abbott Molecular, Inc. | 2010-05-28 |
| HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB (K090191) | Handylab, Inc. | 2010-05-27 |
| SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 (K100148) | Focus Diagnostics, Inc. | 2010-05-24 |
| VITEK 2 YEAST VORICONAZOLE (K092454) | bioMerieux, Inc. | 2010-05-21 |
| IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2, (K100433) | Siemens Healthcare Diagnostics | 2010-05-13 |
| MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 (K100336) | Eragen Biosciences | 2010-05-12 |
| CLEARVIEW EXACT II INFLUENZA A & B TEST (K092349) | Inverness Medical, Inc. | 2010-05-10 |
| HEMOSIL F11 & FV DNA CONTROL (K093737) | Instrumentation Laboratory CO | 2010-05-04 |
| BINAXNOW PBP2A TEST, MODEL 890-000 (K090301) | Binax, Inc. | 2010-04-14 |
| BIOPLEX 2200 MMRV IGG (K091616) | Bio-Rad Laboratories | 2010-03-29 |
| TELAVANCIN 30 UG, BBL SENSI-DISC (K100722) | Becton, Dickinson and Company | 2010-03-29 |
| LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 (K093815) | Millipore Corporation | 2010-03-12 |
| ELECSYS RUBELLA IGM IMMUNOASSAY (K092322) | Roche Diagnostics | 2010-03-12 |
| C. ALBICANS/C. GLABRATA PNA FISH (K092784) | Advandx, Inc. | 2010-03-12 |
| POC-AS10 AUTO SAMPLER (K092817) | Otsuka Pharmaceutical Co., Ltd. | 2010-03-09 |
| CHROMID VRE AGAR, MODEL: REF 43 851 (K091025) | bioMerieux, Inc. | 2010-03-02 |
| SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES (K093741) | Trek Diagnostic Systems, Ltd. | 2010-02-25 |
| CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 (K091766) | Binax, Inc. | 2010-02-24 |
| SAS FLUALERT A&B, SAS INFLUENZA A TEST (K100227) | Sa Scientific, Inc. | 2010-02-23 |
| SENSITITRE 18-24HR SUSCEPTIBILITY PLATES (K093865) | Trek Diagnostic Systems, Inc. | 2010-02-17 |
| MICROSCAN MICROSTREP PLUS, MODEL B1027-201 (K091949) | Siemens Healthcare Diagnostics | 2010-01-26 |
| C. ALBICANS PNA FISH (K092655) | Advandx, Inc. | 2010-01-19 |
| HARDYDISK AST TELAVANCIN,30UG (K093807) | Hardy Diagnostics | 2010-01-08 |
| D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT (K093415) | Diagnostic Hybrids, Inc. | 2009-12-23 |
| Xpert VanA Assay (K092953) | Cepheid | 2009-12-17 |
| E.COLI/P. AERUGINOSA PNA FISH (K092236) | Advandx, Inc. | 2009-12-16 |
| SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES (K092445) | Trek Diagnostic Systems, Ltd. | 2009-12-16 |
| BINAXNOX STAPHYLOCOCCUS AUREUS TEST (K090964) | Binax, Inc. | 2009-12-16 |
| IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM (K091361) | Siemens Healthcare Diagnostics | 2009-12-16 |
| BD GENEOHM MRSA ACP ASSAY (K093346) | Bd Diagnostics (Geneohm Sciences, Inc.) | 2009-12-15 |
| D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT (K093233) | Diagnostic Hybrids, Inc. | 2009-12-04 |
| VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS (K092693) | Viramed Biotech AG | 2009-11-25 |
| S. AUREUS/CNS PNA FISH, MODEL KT005 (K092166) | Advandx, Inc. | 2009-11-23 |
| PROPARAFLU+ASSAY (K091053) | Prodesse, Inc. | 2009-11-20 |
| VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (K093337) | Nanosphere, Inc. | 2009-11-17 |
| BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY (K091724) | Becton, Dickinson & CO | 2009-11-13 |
| BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY (K091730) | Becton, Dickinson & CO | 2009-11-13 |
| DENSICHECK PLUS (K093224) | bioMerieux, Inc. | 2009-11-09 |
| ETEST VORICONAZOLE 0.002-32 UG/ML (K082534) | Ab Biomerieux | 2009-11-02 |
| MONOLISA ANTI-HAV EIA (K092355) | Bio-Rad Laboratories, Inc. | 2009-10-29 |
| MONOLISA ANTI-HAV IGM EIA (K092353) | Bio-Rad Laboratories, Inc. | 2009-10-29 |
| MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025 (K092919) | Siemens Healthcare Diagnostics | 2009-10-23 |
| VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST (K092957) | Nanosphere, Inc. | 2009-10-21 |
| MODIFICATION TO: RAMP INFLUENZA A/B ASSAY (K093116) | Response Biomedical Corp. | 2009-10-21 |
| D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT (K092882) | Diagnostic Hybrids, Inc. | 2009-10-21 |
| VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP) (K092566) | Nanosphere, Inc. | 2009-10-09 |
| OSOM INFLUENZA A&B TEST , MODEL PN190 (K092633) | Genzyme Corporation | 2009-09-25 |
| QUICKVUE INFLUENZA A+B TEST (K092698) | Quidel Corp. | 2009-09-15 |
| D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT (K091171) | Diagnostic Hybrids, Inc. | 2009-09-11 |
| DENSICHEK PLUS (K083536) | bioMerieux, Inc. | 2009-09-11 |
| TRU FLU, MODEL 751230 (K092553) | Meridian Bioscience, Inc. | 2009-09-11 |
| CLEARVIEW ADVANCED STREP A , MODEL 737-430 (K091489) | Binax, Inc. | 2009-09-04 |
| EK/P. AERUGINOSA PNA FISH (K092393) | Advandx, Inc. | 2009-09-01 |
| ELVIS HSV ID AND D3 TYPING TEST SYSTEM (K091753) | Diagnostic Hybrids, Inc. | 2009-08-28 |
| MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT (K092300) | Diagnostic Hybrids, Inc. | 2009-08-28 |
| XPECT FLU A & B (K092423) | Thermo Fisher Scientific | 2009-08-26 |
| MODIFICATION TO PROFLU+ ASSAY (K092500) | Prodesse, Inc. | 2009-08-20 |
| S. AUREUS PNA FISH (K091827) | Advandx, Inc. | 2009-08-18 |
| VITEK 2 GRAM NEGATIVE MEROPENEM (K091899) | bioMerieux, Inc. | 2009-08-14 |
| MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST (K092223) | Binax, Inc. | 2009-08-12 |
| VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE (K082329) | Viramed Biotech AG | 2009-08-05 |
| AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT (K083074) | Advandx, Inc. | 2009-07-24 |