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Microbiology

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

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RecordFirmDate
RAMP RSV ASSAY (K091235)Response Biomedical Corp.2009-07-24
SAS INFLUENZA A & B TEST (K080380)Sa Scientific, Inc.2009-07-23
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017 (K091264)Siemens Healthcare Diagnostics2009-07-22
CHROMID MRSA AGAR, MODEL: REF 43 841 (K091024)bioMerieux, Inc.2009-07-17
XPERT C. DIFFICILE (K091109)Cepheid2009-07-09
PLATELIA TOXO IGM KIT MODEL 26211 (K090847)Bio-Rad Laboratories2009-07-01
E. COLI PNA FISH (K082068)Advandx, Inc.2009-06-25
XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116 (K091667)Luminex Molecular Diagnostics, Inc.2009-06-25
VITEK 2 GRAM POSITIVE DAPTOMYCIN (K091126)bioMerieux, Inc.2009-06-18
SERAQUEST EBV EA-D IGG TEST (K091260)Quest Intl., Inc.2009-06-08
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY (K090971)Becton, Dickinson & CO2009-06-05
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES (K090968)Trek Diagnostic Systems, Inc.2009-06-04
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY (K090824)Becton, Dickinson & CO2009-06-02
IMMUNOCARD STAT CAMPY, MODEL 751530 (K090700)Meridian Bioscience, Inc.2009-05-28
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY (K090827)Becton, Dickinson & CO2009-05-27
BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K090409)Bio-Rad Laboratories2009-05-08
GBS PNA FISH (K082612)Advandx, Inc.2009-05-05
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST (K083088)Nanosphere, Inc.2009-05-01
PROGASTRO CD ASSAY (K090239)Prodesse, Inc.2009-04-16
ORTHO T. CRUZI ELISA TEST SYSTEM (K072732)Ortho-Clinical Diagnostics, Inc.2009-04-15
AVC A/H5N1 FLU TEST (K083278)Arbor Vita Corportation2009-04-08
LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT (K081527)Millipore Corporation2009-04-01
C. DIFF QUIK CHEK COMPLETE (K082499)Techlab, Inc.2009-03-26
EK/P. AERUGINOSA PNA FISH (K081433)Advandx, Inc.2009-03-26
SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES (K083606)Trek Diagnostic Systems, Inc.2009-03-24
VITEK 2 GRAM NEGATIVE DORIPENEM (K082346)bioMerieux, Inc.2009-03-16
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS (K081063)Trek Diagnostic Systems, Inc.2009-03-06
D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT (K090073)Diagnostic Hybrids, Inc.2009-03-06
BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET (K080008)Bio-Rad Laboratories, Inc.2009-02-23
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE (K083383)bioMerieux, Inc.2009-02-18
MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML) (K083262)Siemens Healthcare Diagnostics2009-02-18
PREMIER CAMPY, MODEL 618096 (K083464)Meridian Bioscience, Inc.2009-01-30
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML (K082852)Becton, Dickinson & CO2009-01-29
GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF (K081064)Ivd Research, Inc.2009-01-14
VIROCULT, MODEL MW950 (K082472)Medical Wire & Equipment Company (Bath), Ltd.2008-12-30
BD BACTEC Plus Aerobic/F Culture Vials (K083572)Becton, Dickinson & CO2008-12-24
D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT (K081928)Diagnostic Hybrids, Inc.2008-12-23
VIDAS RUB IGG (K080766)bioMerieux, Inc.2008-12-23
D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT (K081746)Diagnostic Hybrids, Inc.2008-12-23
BD GENEOHM CDIFF ASSAY (K081920)Bd Diagnostics (Geneohm Sciences, Inc.)2008-12-19
E.COLI/P. AERUGINOSA PNA FISH (K081309)Advandx, Inc.2008-12-19
INTROL CF PANEL I CONTROL, MODEL: G106 (K083171)Maine Molecular Quality Controls, Inc.2008-12-16
BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY (K081825)Becton, Dickinson & CO2008-12-11
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY (K081824)Becton, Dickinson & CO2008-12-11
ELECSYS RUBELLA IGG IMMUNOASSAY (K072617)Roche Diagnostics Corp.2008-12-05
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML (K082913)Becton, Dickinson & CO2008-12-05
LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV (K082049)DiaSorin, Inc.2008-12-05
DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS (K073390)DiaSorin, Inc.2008-11-21
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST (K082538)Becton, Dickinson & CO2008-11-20
LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG (K081685)DiaSorin, Inc.2008-11-18
LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG (K081687)DiaSorin, Inc.2008-11-10
PRO HMPV+ ASSAY (K082688)Prodesse, Inc.2008-11-07
LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM (K082050)DiaSorin, Inc.2008-11-03
SENSITITRE VIZION (K081520)Trek Diagnostic Systems, Inc.2008-10-24
FLUCONAZOLE 25UG BBL SENSI-DISC (K082271)Becton, Dickinson & CO2008-10-06
BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A (K082661)Princeton BioMeditech Corp.2008-10-06
VORICONAZOLE 1UG BBL SENSI-DISC (K082272)Becton, Dickinson & CO2008-10-02
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL (K080570)Centers for Disease Control and Prevention2008-09-30
XPERT MRSA/SA BLOOD CULTURE ASSAY (K082140)Cepheid2008-09-29
XPERT MRSA/SA SSTI ASSAY (K080837)Cepheid2008-09-24
YEAST TRAFFIC LIGHT PNA FISH (K080719)Advandx, Inc.2008-09-12
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN (K081013)Siemens Healthcare Diagnostics2008-09-08
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN (K081182)Siemens2008-08-08
PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M (K073381)Focus Diagnostics, Inc.2008-08-04
PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G (K073382)Focus Diagnostics, Inc.2008-07-28
ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML (K081325)Ab Biodisk2008-07-24
ADVIA CENTAUR HAVM ASSAY (K081716)Siemens Healthcare Diagnostics, Inc.2008-07-17
ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT (K080739)Abbott Molecular, Inc.2008-07-10
PLATELIA LYME IGM (K081362)Bio-Rad2008-06-26
XTAG RESPIRATORY VIRAL PANEL (K081483)Luminex Molecular Diagnostics, Inc.2008-06-25
NUCLISENS EASYQ ENTEROVIRUS SYSTEM (K063261)bioMerieux, Inc.2008-06-23
MRSASELECT - EXTENDED INCUBATION (K081212)Bio-Rad2008-06-13
D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT (K081164)Diagnostic Hybrids, Inc.2008-06-13
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY (K080931)bioMerieux, Inc.2008-06-11
ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG (K073501)Roche Diagnostics Corp.2008-06-09
ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM (K072178)Zeus Scientific, Inc.2008-05-30
ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC (K080869)Beckman Coulter, Inc.2008-05-23
DORIPENEM 10UG BBL SENSI-DISC (K080998)Becton, Dickinson & CO2008-05-12
PLATELIA LYME IGG ASSAY (K080012)Bio-Rad2008-05-08
MODIFICATION TO PROFLU+ ASSAY (K081030)Prodesse, Inc.2008-05-02
VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE (K080201)bioMerieux, Inc.2008-04-30
RAMP INFLUENZA A/B ASSAY (K071591)Response Biomedical Corp.2008-04-16
B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM (K070310)Brahms Aktiengesellschaft2008-03-31
SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE (K073653)Trek Diagnostic Systems, Inc.2008-03-20
SENSITITRE 18-24 SUSCEPTIBILITY PLATE (K073558)Trek Diagnostic Systems, Inc.2008-03-13
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS (K073589)Becton, Dickinson & CO2008-03-05
SPECTRA MRSA (K073027)Thermo Fisher Scientific2008-02-28
VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM (K080107)bioMerieux, Inc.2008-02-28
HARDYDISK AST DORIPENEM 10 UG (K080019)Hardy Diagnostics2008-01-29
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE (K073406)bioMerieux, Inc.2008-01-23
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES (K073424)Trek Diagnostic Systems, Inc.2008-01-22
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML (K073433)Becton, Dickinson & CO2008-01-14
PROFLU+ ASSAY (K073029)Prodesse, Inc.2008-01-04
ID-TAG RESPIRATORY VIRAL PANEL (DEN070013)Luminex Molecular Diagnostics, Inc.2008-01-03
VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 (K072138)bioMerieux, Inc.2007-12-21
BD GENEOHM STAPHSR ASSAY (K071026)Bd Diagnostics (Geneohm Sciences Canada, Inc)2007-12-20
JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 (K072631)Idaho Technology, Inc.2007-12-20
JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124 (K072547)Idaho Technology, Inc.2007-12-19
VITEK 2 GRAM NEGATIVE PIPERACILLIN (K073083)bioMerieux, Inc.2007-12-10
RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE (K072827)Remel, Inc.2007-11-26
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