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Microbiology

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

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RecordFirmDate
IS EBV-EA-D IGG ELISA TEST SYSTEM (K981831)Diamedix Corp.1999-02-16
IS EBV-EBNA-1 IGG ELISA TEST SYSTEM (K981829)Diamedix Corp.1999-02-16
PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY (K981913)Chembio Diagnostic Systems, Inc.1999-02-12
UNI-GOLD STREP A TEST KIT (K982373)Trinity Biotech, Plc1999-02-11
SYSTEM U3 FOR AMOXICILLIN/CLAVULANIC ACID (K984144)Ab Biodisk1999-02-09
SYSTEM U3 FOR AMPICILLIN (K984087)Ab Biodisk1999-02-08
IS-RUBELLA IGG TEST SYSTEM (K981729)Diamedix Corp.1999-01-28
THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)F (K984317)Zeus Scientific, Inc.1999-01-22
THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM (K984181)Zeus Scientific, Inc.1999-01-22
THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELISA TEST SYSTEM (K984170)Zeus Scientific, Inc.1999-01-19
SERAQUEST CMV IGM (K982485)Quest Intl., Inc.1999-01-13
NETILMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K984036)Oxoid , Ltd.1999-01-13
MB/BACT BLOOD CULTURE BOTTLE (K983772)Organon Teknika Corp.1999-01-13
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE (K984139)Zeus Scientific, Inc.1999-01-11
GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY (K983399)Genzyme Diagnostics1999-01-11
THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH (K984133)Zeus Scientific, Inc.1999-01-11
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR (K984126)Zeus Scientific, Inc.1999-01-11
THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E (K984123)Zeus Scientific, Inc.1999-01-11
THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM. (K984153)Zeus Scientific, Inc.1999-01-11
SYSTEM U3 FOR NITROFURANTOIN (K983565)Ab Biodisk1999-01-05
SYSTEM U3 FOR TETRACYCLINE (K983571)Ab Biodisk1998-12-30
SYSTEM U3 FOR NORFLOXACIN (K983486)Ab Biodisk1998-12-23
LIGHT DIAGNOSTICS RABIES DFA REAGENT (K972975)Light Diagnostics1998-12-22
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN (K983306)Accumed Intl., Inc.1998-12-18
MODIFICATION TO: PREMIER PLATINUM HPSA (K983255)Meridian Diagnostics, Inc.1998-12-17
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN (K983310)Accumed Intl., Inc.1998-12-17
IS BORRELIA BURGDORFERI IGM TEST SYSTEM (K983606)Columbia Bioscience, Inc.1998-12-16
IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (K983605)Columbia Bioscience, Inc.1998-12-16
ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS (K973718)Roche Molecular Systems, Inc.1998-12-15
BARTELS CINAKIT CMV ANTIGENEMIA (K982311)Intracel Corp.1998-12-14
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE (K983803)Zeus Scientific, Inc.1998-12-14
SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN (K983309)Accumed Intl., Inc.1998-12-14
MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K983718)Oxoid , Ltd.1998-12-11
IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS) (K982078)Diagnostic Products Corp.1998-12-11
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO (K983801)Zeus Scientific, Inc.1998-12-10
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR (K983804)Zeus Scientific, Inc.1998-12-08
PREMIER CRYPTOSPORIDIUM (K982764)Meridian Diagnostics, Inc.1998-12-03
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM) (K983244)Trek Diagnostic Systems, Inc.1998-11-30
EA-D IGM ELISA TEST SYSTEM (K982350)Columbia Bioscience, Inc.1998-11-25
SYSTEM U3 FOR TRIMETHOPRIM/SULFAMETHOXAZOLE (K983259)Ab Biodisk1998-11-25
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN (K983301)Accumed Intl., Inc.1998-11-25
BIOSTREP A-DIRECT STREP A ANTIGEN TEST (K983386)Princeton BioMeditech Corp.1998-11-25
PREMIER GIARDIA (K982711)Meridian Diagnostics, Inc.1998-11-25
MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY (K982027)DiaSorin, Inc.1998-11-25
EBNA-1 IGM ELISA TEST SYSTEM (K982348)Columbia Bioscience, Inc.1998-11-25
AB FLU OIA (K981651)Biostar, Inc.1998-11-25
VCA IGM ELISA TEST SYSTEM (K982352)Columbia Bioscience, Inc.1998-11-25
SYSTEM U3 FOR GENTAMICIN (K983252)Ab Biodisk North America, Inc.1998-11-20
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN (K981199)Dade Microscan, Inc.1998-11-18
PROSPECT CAMPYLOBACTER MICROPLATE ASSAY (K982315)Alexon - Trend, Inc.1998-11-18
ABBOTT TESTPACK PLUS H. PYLORI (K982362)Abbott Laboratories1998-11-18
QUANTA LITE H. PYLORI IGG ELISA (K982790)Inova Diagnostics, Inc.1998-11-04
SERAQUEST RUBELLA IGM (K982281)Quest Intl., Inc.1998-10-16
URISCREEN (K981084)Diatech Diagnostics,Inc.1998-10-07
TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA (K982245)Biosite Incorporated1998-10-06
TRIMETHOPRIM/SULPHAMETHOXAZOLE (K983027)Ab Biodisk1998-10-02
ETEST RIFAMPICIN WITH INDICATIONS FOR S. PNEUMONIAE (K982868)Ab Biodisk1998-09-30
DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM (K981306)Diamedix Corp.1998-09-29
HYBRID CAPTURE SYSTEM CMV DNA ASSAY (K974901)Digene Corp.1998-09-29
IS-VZU IGG TEST SYSTEM (K981867)Diamedix Corp.1998-09-28
IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3 (K981226)Dako Diagnostics , Ltd.1998-09-28
GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820 (K974572)Chugai Pharmaceuticals Co., Ltd.1998-09-24
VTEC-RPLA SEIKEN (K981734)Denka Seiken'S1998-09-22
BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST (K980798)Princeton BioMeditech Corp.1998-09-22
IMMUNODOT MONO-G TEST (K974226)Genbio1998-09-22
IMMUNODOT MONO-M TEST (K974244)Genbio1998-09-22
DIAMEDIX IS-CMV IGG TEST SYSTEM (K981163)Diamedix Corp.1998-09-21
ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469 (K973448)Beckman Instruments, Inc.1998-09-17
SPARFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K982526)Oxoid , Ltd.1998-09-09
AMOXICILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K982524)Oxoid , Ltd.1998-09-09
NAFCILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K982528)Oxoid , Ltd.1998-09-09
CEFPROZIL ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K982517)Oxoid , Ltd.1998-09-09
SULFISOXAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K982523)Oxoid , Ltd.1998-09-09
OXOID STREPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K982669)Oxoid , Ltd.1998-09-09
CEFONICID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K982520)Oxoid , Ltd.1998-09-09
LEVOFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K982519)Oxoid , Ltd.1998-09-09
SYSTEM U3 FOR CIPROFLOXACIN (K981639)Ab Biodisk1998-09-03
MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY (K982709)Alexon - Trend, Inc.1998-09-03
ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES (K982429)Zymetx, Inc.1998-08-25
BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522 (K982238)Binax, Inc.1998-08-21
IS-TOXOPLASMA IGG TEST SYSTEM (K981498)Diamedix Corp.1998-08-21
ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA (K981120)Zeus Scientific, Inc.1998-08-21
MB/BACT BLOOD CULTURE BOTTLE (K982263)Organon Teknika Corp.1998-08-18
IMMUNOWELL VCA IGM TEST (K973939)Genbio1998-08-10
IMMUNOWELL EBV VCA IGG TEST (K973940)Genbio1998-08-10
IMMUNOWELL EBNA IGG TEST (K973941)Genbio1998-08-10
TOXOGEN (K981263)Instrumentation Laboratory CO1998-08-06
STAT-SIMPLE PYLORI (K980782)Saliva Diagnostic Systems, Inc.1998-08-05
DIPSTREAK (K974428)Novamed , Ltd.1998-07-30
PYLORIPROBE (K981396)Amdl, Inc.1998-07-30
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM (K980821)Zeus Scientific, Inc.1998-07-30
PASCO MIC AND MIC/ID PANELS (K982235)Pasco Laboratories, Inc.1998-07-30
BACT/ALERT 3D MICROBIAL DETECTION SYSTEM (K981736)Organon Teknika Corp.1998-07-24
VCA IGM ELISA TEST SYSTEM (K980596)Clark Laboratories, Inc.1998-07-22
VCA IGG ELISA TEST SYSTEM (K980912)Clark Laboratories, Inc.1998-07-22
COLORPAC TOXIN A (K980185)Bd Becton Dickinson Vacutainer Systems Preanalytic1998-07-17
PAR-ONE (K981391)Remel, Inc.1998-07-14
MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA (K982210)Dade Behring, Inc.1998-07-09
ETEST CEFDINIR (K980877)Ab Biodisk1998-07-06
ADI SYPHILIS RPR LIQUID CONTROLS (K980638)Ampcor Diagnostics, Inc.1998-07-06
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