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Microbiology

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

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RecordFirmDate
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0.03125 -4 UG/ML (K051272)Becton, Dickinson & CO2005-07-11
BD DIRECTIGEN EZ FLU A + B (K042472)Becton, Dickinson & CO2005-07-07
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.25 - 16UG/ML (K051266)Becton, Dickinson & CO2005-07-05
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFEPIME (STREP) 0.0625-4UG/ML (K051204)Becton, Dickinson & CO2005-06-24
DRIED GRAM-POSITIVE MIC/COMBO PANELS (K051202)Dade Behring, Inc.2005-06-23
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GATIFLOXACIN (STREP) 0.0625 -8UG/ML (K051183)Becton, Dickinson & CO2005-06-21
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN (STREP) 0.0156 - 4UG/ML (K051109)Becton, Dickinson & CO2005-06-15
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (STREP) 0.0625 - 4UG/ML (K051138)Becton, Dickinson & CO2005-06-03
DIASORIN LIAISON CMV IGM/IGG (K040290)Diasorin S.P.A2005-06-01
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML (K050946)Becton, Dickinson & CO2005-05-27
BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML) (K050982)Becton, Dickinson & CO2005-05-24
VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE (K050976)bioMerieux, Inc.2005-05-23
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TRIMETHOPRIM-SULFAMETHOXAZOLE 0.0625/1.2-16/304 UG/ML (K050865)Becton, Dickinson & CO2005-05-20
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE (STREP) 0.0625 - 16 UG/ML (K050881)Becton, Dickinson & CO2005-05-12
BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML (K050780)Becton, Dickinson & CO2005-05-12
VITEK 2 GRAM POSITIVE MEROPENEM (K050816)bioMerieux, Inc.2005-05-12
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, LEVOFLOXACIN (STREP) 0.25-16 UG/ML (K050747)Becton, Dickinson & CO2005-04-29
DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS (K040120)DiaSorin, Inc.2005-04-29
ATHENA MULTI-LYTE EBV IGG TEST SYSTEM (K042118)Zeus Scientific, Inc.2005-04-29
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML (K050745)Becton, Dickinson & CO2005-04-29
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GP) 2-32 UG/ML (K050555)Becton, Dickinson & CO2005-04-14
ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM (K042092)Zeus Scientific, Inc.2005-04-12
MODIFICATION TO BVBLUE (K050755)Gryphus Diagnostics, LLC2005-04-06
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (K050043)Dade Behring, Inc.2005-03-29
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML (K050400)Becton, Dickinson & CO2005-03-22
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE (K050585)Dade Behring, Inc.2005-03-18
IMMUNOCARD STAT! FLU A & B (K041626)Meridian Bioscience, Inc.2005-03-16
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTETAN (GN) 2-64 UG/ML (K043458)Becton, Dickinson & CO2005-03-15
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE (K043144)Gen-Probe, Inc.2005-03-14
VITEK 2 GRAM POSITIVE DAPTOMYCIN (K050075)bioMerieux, Inc.2005-02-28
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN-SULBACTAM (GP) 2-32 UG/ML (K050089)Becton, Dickinson & CO2005-02-28
VITEK 2 GRAM POSITIVE ERTAPENEM (K050076)bioMerieux, Inc.2005-02-18
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML) (K043545)Dade Behring, Inc.2005-02-17
VITEK 2 COMPACT (K050002)bioMerieux, Inc.2005-02-17
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM (K043589)Dade Microscan, Inc.2005-02-14
GEMIFLOXACIN, 5UG BBL SENSI-DISC (K050062)Becton, Dickinson & CO2005-02-10
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS (K043072)Gen-Probe, Inc.2005-01-27
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN) 0.5/0.25-32/16UG/ML (K043389)Becton, Dickinson & CO2005-01-21
B-R-A-H-M-S PCT LIA (K040887)Brahms Aktiengesellschaft2005-01-07
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM (K043230)bioMerieux, Inc.2004-12-30
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN (K043237)bioMerieux, Inc.2004-12-23
DAPTOMYCIN (K042392)Ab Biodisk2004-12-13
HELICOBACTER PYLORI IGG ELISA (K041238)Biohit Plc2004-12-13
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM (K042963)bioMerieux, Inc.2004-12-13
COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM (K042970)Copan Diagnostics, Inc.2004-12-07
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN (K042946)bioMerieux, Inc.2004-12-07
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM 0.5/4-128/4 UG/ML (K042932)Becton, Dickinson & CO2004-12-02
STATUS FIRST STREP A (K040708)Princeton BioMeditech Corp.2004-11-22
BBLCHROMAGAR MRSA (K042812)Becton, Dickinson & CO2004-11-22
WEST NILE DETECT IGM ELISA (K041817)Inbios Intl., Inc.2004-11-19
ETEST FOR GEMIFLOXACIN (K042390)Ab Biodisk2004-11-19
XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B (K041951)Remel, Inc.2004-11-15
IDI-MRSA ASSAY (K042357)Infectio Diagnostic (I.D.I.), Inc.2004-10-22
WEST NILE VIRUS IGG INDIRECT ELISA (K041068)Panbio Limited2004-10-20
PASCO MIC AND MIC/ID PANELS (K042331)Pasco Laboratories, Inc.2004-10-07
VITEK 2 GRAM NEGATIVE ERTAPENEM (K041982)bioMerieux, Inc.2004-09-14
DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K042157)Oxoid , Ltd.2004-09-14
IMMUNOCARD TOXINS A & B, MODEL 712050 (K041003)Meridian Bioscience, Inc.2004-08-20
IMMUNOCARD STAT! RSV MODEL #750630 (K041445)Meridian Bioscience, Inc.2004-08-13
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-128 UG/ML (K041572)Becton, Dickinson and Co.2004-08-12
BINAXNOW INFLUENZA A & B TEST (K041049)Binax, Inc.2004-08-10
WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M (K041231)Panbio Limited2004-08-10
PASCO MIC AND MIC/ID PANELS (K041776)Pasco Laboratories, Inc.2004-08-03
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVE (K041384)Becton, Dickinson & CO2004-08-03
ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING (K040560)Ab Biodisk2004-07-27
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL (K041534)Trek Diagnostic Systems, Ltd.2004-07-27
SAS INFLUENZA A TEST (K041441)Sa Scientific, Inc.2004-07-22
SAS INFLUENZA B TEST (K041439)Sa Scientific, Inc.2004-07-22
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS (K041150)Dade Behring, Inc.2004-07-22
POCONE INFRARED SPECTROPHOTOMETER (K041148)Otsuka Pharmaceutical Co., Ltd.2004-07-15
CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT (K033106)Trinity Biotech USA2004-07-13
CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT (K033105)Trinity Biotech USA2004-07-13
WEST NILE VIRUS IGM CAPTURE ELISA (K040854)Focus Technologies, Inc.2004-06-30
VITEK 2 ESBL TEST (K040845)bioMerieux, Inc.2004-06-08
PASCO MIC AND MIC/ID PANELS (K041214)Pasco Laboratories, Inc.2004-06-07
QUICKELISA ANTHRAX-PA KIT (K040407)Immunetics, Inc.2004-06-03
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST (K033458)Becton, Dickinson & CO2004-05-28
C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96 (K032897)Ivd Research, Inc.2004-05-27
GLUCATELL (DEN040003)Associates of Cape Cod, Inc.2004-05-21
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PENICILLIN (GP) 0.0625-32 UG/ML (K040716)Becton, Dickinson & CO2004-05-14
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES (K040846)Trek Diagnostic Systems, Inc.2004-04-26
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5 - 16/304 UG/ML (K033907)Becton, Dickinson & CO2004-04-09
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE (K033362)Becton, Dickinson & CO2004-04-09
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES (K040619)Trek Diagnostic Systems, Inc.2004-04-07
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML) (K031601)Dade Behring, Inc.2004-04-02
GENZYME OSOM TRICHOMONAS RAPID TEST (K033864)Genzyme Corp.2004-04-02
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM (K040099)Becton, Dickinson & CO2004-03-19
IDI-MRSA (K033415)Infectio Diagnostic (I.D.I.), Inc.2004-03-18
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -- AMPICILLIN -- GRAM POSITIVE (K040106)Becton, Dickinson & CO2004-03-11
BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY (K033861)Becton, Dickinson & CO2004-03-09
CT OIA (K032330)Thermo Biostar, Inc.2004-03-02
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/ML (K032675)Becton, Dickinson & CO2004-03-01
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN) (K033948)Dade Behring, Inc.2004-03-01
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-LINEZOLID-GRAM POSITIVE (K040006)Becton, Dickinson & CO2004-02-27
PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY (K033479)Remel, Inc.2004-02-26
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN) (K033940)Dade Behring, Inc.2004-02-25
WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 (K023889)Wiener Laboratories Saic2004-02-11
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML (K032706)Dade Behring, Inc.2004-02-10
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT CHLORAMPHENICOL 1-32 UG/ML GRAM POSITIVE (K033889)Becton, Dickinson & CO2004-02-03
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML (K033784)Becton, Dickinson & CO2004-02-03
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