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Microbiology

6,936 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN (GN) 1-128 UG/ML (K062680)Becton, Dickinson & CO2006-10-05
TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 (K061509)Gen-Probe, Inc.2006-10-04
MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN (K062585)Dade Behring, Inc.2006-09-19
MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID (K062596)Dade Behring, Inc.2006-09-19
VITEK 2 AST-YS FLUCONAZOLE (K061945)bioMerieux, Inc.2006-09-19
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS (K060770)Ortho-Clinical Diagnostics, Inc.2006-09-15
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS (K060678)Ortho-Clinical Diagnostics, Inc.2006-09-14
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64 UG/ML (K062207)Becton, Dickinson & CO2006-09-13
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K062022)Trek Diagnostic Systems, Inc.2006-09-11
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML (K062206)Becton, Dickinson & CO2006-09-08
QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199 (K061008)Quidel Corp.2006-09-08
MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML) (K062290)Dade Behring, Inc.2006-09-01
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES (K062190)Trek Diagnostic Systems, Inc.2006-08-31
IDI-VANR ASSAY (K061686)Geneohm Sciences Canada, Inc.2006-08-30
MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML) (K062293)Dade Behring, Inc.2006-08-24
HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936 (K062245)Hardy Diagnostics2006-08-23
MICROSCAN MICROSTREP PLUS PANEL (K061872)Dade Behring, Inc.2006-08-23
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/ML) (K062179)Dade Behring, Inc.2006-08-23
MICROSCAN MICROSTREP PLUS PANEL (K062276)Dade Behring, Inc.2006-08-23
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM (GP) 1/4-128/4 UG/ML (K061869)Becton, Dickinson & CO2006-08-18
TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY (K060652)Gen-Probe, Inc.2006-08-17
COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS (K053287)Roche Diagnostics Corp.2006-08-10
ENZY-WELL SYPHILIS IGG, MODEL 91106 (K050590)Diesse Diagnostica Senese S.P.A.2006-08-10
COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE (K053289)Roche Diagnostics Corp.2006-08-10
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFAZOLIN (GN) 0.5-32 UG/ML (K061867)Becton, Dickinson & CO2006-08-10
TREP-SURE TREPONEMAL ANTIBODY EIA (K053570)Phoenix Biotech Corp.2006-08-07
DIASORIN LIAISON TREPONEMA ASSAY (K061247)DiaSorin, Inc.2006-07-31
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE(GP) 0.25/0.12 -32/16 UG/ML (K061673)Becton, Dickinson & CO2006-07-28
XPERT, GENEXPERT DX SYSTEM (K060540)Cepheid2006-07-25
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 (K053446)Gen-Probe, Inc.2006-07-25
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS (K061687)Dade Behring, Inc.2006-07-21
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS (K061536)Dade Behring, Inc.2006-07-18
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE (GN) 0.5/0.25-32/16 UG/ML, AMPICILLIN-SULBACTAM (GN) 0. (K061327)Becton, Dickinson & CO2006-07-03
COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM (K061301)Copan Diagnostics, Inc.2006-06-23
VITEK 2 GRAM POSITIVE VRSA SCREEN (K061347)bioMerieux, Inc.2006-06-20
OSOM INFLUENZA A&B TEST (K061508)Genzyme Corp.2006-06-12
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN (GN) 0.5-32 UG/ML (K061355)Becton, Dickinson & CO2006-06-07
PLATELIA ASPERGILLUS EIA, MODEL 62793 (K060641)Bio-Rad2006-06-02
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT GATIFLOXACIN 0.25-8 UG/ML - GRAM-NEGATIVE (K060324)Becton, Dickinson & CO2006-05-25
SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL (K060783)Trek Diagnostic Systems, Inc.2006-05-16
PARA-PRO FC50 (K053257)Alpha-Tec Systems, Inc.2006-05-12
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEPHALOTHIN - GN 1 - 64 UG/ML (K060558)Becton, Dickinson & CO2006-05-11
S. AUREUS PNA FISH (K060099)Advandx, Inc.2006-05-08
PYLO-PLUS (K052708)Arj Medical, Inc.2006-05-01
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -NITROFURANTOIN (GN) 8-512 UG/ML, TRIMETHOPRIM-SULFAMETHOXAZOLE (GN) (K060447)Becton, Dickinson & CO2006-04-26
C. DIFF QUIK CHEK (K053572)Techlab, Inc.2006-04-26
SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015- (K060621)Tds Holdings, Inc.2006-04-21
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN - 0.5-64 UG/ML (K060257)Becton, Dickinson & CO2006-04-14
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN-0.125-8 AND CIPROFLOXACIN-0.25 - 4 UG/ML (K060217)Becton, Dickinson & CO2006-04-12
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) , CEFTRIAXONE (GN), CEFOTAXIME (GN), 0.5-64 UG/ML (K060444)Becton, Dickinson & CO2006-04-12
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN-GP DETECTION OF VRSA. (K060493)Becton, Dickinson & CO2006-03-29
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH VANCOMYCIN (0.25-64 UG/ML) (K060312)Dade Behring, Inc.2006-03-23
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN-0.0625-8 UG/ML, AND QUINUPRISTIN/DALFOPRISTIN-0.25-4 UG/ML (K060218)Becton, Dickinson & CO2006-03-17
TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K060286)Oxoid , Ltd.2006-03-17
PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480 (K053335)Meridian Bioscience, Inc.2006-03-10
BD PHOENIX AUTOMATED MIRCROBIOLOGY SYSTEM TETRACYCLINE-GN 0.5-16 UG/ML AND GP 0.5-16 UG/ML (K060214)Becton, Dickinson & CO2006-03-09
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML) (K053504)Dade Behring, Inc.2006-02-24
GENZYME OSOM INFLUENZA A & B TEST (K051244)Genzyme Corp.2006-02-21
DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS (K052499)Diasorin S.P.A2006-02-08
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - AMPICILLIN (K060088)Dade Behring, Inc.2006-02-03
INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET (DEN060008)Centers for Disease Control and Prevention2006-02-03
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (K053243)Trek Diagnostic Systems, Inc.2006-01-20
VERSATREK MYCO PZA KIT (K052323)Trek Diagnostic Systems, Inc.2006-01-19
SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF (K052485)Midi, Inc.2006-01-17
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN GP 1-32 G/ML (K053241)Becton, Dickinson & CO2005-12-22
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873; (K052645)Ortho-Clinical Diagnostics2005-12-14
VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN (K053097)bioMerieux, Inc.2005-12-14
QUICKVUE INFLUENZA A + B TEST (K053146)Quidel Corp.2005-12-14
INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC (K051638)Unipath , Ltd.2005-12-06
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. (K051484)Zeus Scientific, Inc.2005-12-05
VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE (K053186)bioMerieux, Inc.2005-12-01
BINAXNOW INFLUENZA A & B TEST (K053126)Binax, Inc.2005-11-30
BD VIPER SYSTEM (K052481)Becton, Dickinson & CO2005-11-28
RPS ADENO DETECTOR (K052092)Rapid Pathogen Screening2005-11-22
JBAIDS ANTHRAC DETECTION SYSTEM (K051713)Idaho Technology, Inc.2005-11-18
TIGECYCLINE 15UG BBL SENSI-DISC (K052853)Becton, Dickinson & CO2005-11-17
GIARDIA/CRYPTOSPORIDIUM CHEK (K051929)Techlab, Inc.2005-11-17
TELITHROMYCIN 15UG BBL SENSI-DISC (K052876)Becton, Dickinson & CO2005-11-14
VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN (K052656)bioMerieux, Inc.2005-11-07
CRYPTOSPORIDIUM II (K052932)Techlab, Inc.2005-11-04
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS (K052346)Dade Behring, Inc.2005-10-26
ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA (K052366)Ab Biodisk2005-10-13
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (STREP) 0.125 - 4UG/ML (K052270)Becton, Dickinson & CO2005-10-05
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -CIPROFLOXACIN GN (K052269)Becton, Dickinson & CO2005-10-03
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML (K052250)Becton, Dickinson & CO2005-09-30
VITEK 2 GRAM NEGATIVE TIGECYCLINE (K052311)bioMerieux, Inc.2005-09-29
SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS (K052091)Trek Diagnostic Systems, Inc.2005-09-21
BD PROBE TEC URINE PRESERVATIVE TRANSPORT (K052224)Becton, Dickinson & CO2005-09-12
IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT (K050352)Ameritek Research, LLC2005-09-01
GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS (K051794)Office of the Surgeon General, U.S. Army2005-08-16
VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE (K051849)bioMerieux, Inc.2005-08-16
VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT (K051071)Viramed Biotech AG2005-08-11
BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT (K051169)Viramed Biotech AG2005-08-11
GEN-PROBE APTIMA COMBO 2 ASSAY (K043224)Gen-Probe, Inc.2005-08-09
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - DAPTOMYCIN 0.125 - 32 UG/ML (K051689)Becton, Dickinson & CO2005-08-05
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMPIN (K051478)Dade Behring, Inc.2005-07-27
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS (K051350)Dade Behring, Inc.2005-07-25
TOX A/B QUICK CHEK (K050891)Techlab, Inc.2005-07-25
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMOXICILLIN (STREP) 0.0313 - 32 UG/ML (K051692)Becton, Dickinson & CO2005-07-14
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCENTRATION/COMBO PANELS - LEVOFLOXACIN (K051311)Dade Behring, Inc.2005-07-12
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