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Microbiology

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

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RecordFirmDate
EBNA IGG ELISA TEST (K935730)Gull Laboratories, Inc.1995-09-19
EBV-EA(D) IGG ELISA TEST (K940093)Gull Laboratories, Inc.1995-09-15
POLIOVIRUS BLEND MONOCLONAL ANTIBODIES (K940026)Light Diagnostics1995-09-12
ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES (K940027)Chemicon Intl., Inc.1995-09-12
ENTEROVIRUS 71 MONOCLONAL ANTIBODY (K940473)Chemicon Intl., Inc.1995-09-12
POLIOVIRUS 2 MONOCLONAL ANTIBODY (K940034)Light Diagnostics1995-09-12
POLIOVIRUS 3 MONOCLONAL ANTIBODY (K940017)Light Diagnostics1995-09-12
COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY (K936254)Light Diagnostics1995-09-08
COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY (K936251)Light Diagnostics1995-09-08
ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS (K936073)Chemicon Intl., Inc.1995-09-08
COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES (K940471)Chemicon Intl., Inc.1995-09-08
COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY (K936089)Chemicon Intl., Inc.1995-09-08
COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY (K936252)Light Diagnostics1995-09-08
POLIOVIRUS 1 MONOCLONAL ANTIBODY (K940018)Light Diagnostics1995-09-08
ENTEROVIRUS 70 MONCLONAL ANTIBODY (K940363)Light Diagnostics1995-09-08
COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY (K936253)Light Diagnostics1995-09-08
COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY (K940472)Chemicon Intl., Inc.1995-09-08
MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION) (K952873)Medix Biotech, Inc.1995-09-08
COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY (K936145)Chemicon Intl., Inc.1995-09-08
QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU (K935475)Syntron Bioresearch, Inc.1995-08-30
QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY (K935554)Syntron Bioresearch, Inc.1995-08-30
LYFO(TM) DIFFERENTIAL DISK (K951889)Microbiologics, Inc.1995-08-24
VZV IGG ELISA TEST (K941046)Gull Laboratories, Inc.1995-08-24
EBV LGG ELISA TEST (K941198)Gull Laboratories, Inc.1995-08-23
RUBELISA (RUBESTAT) (K950227)Bio-Whittaker, Inc., A Cambrex Co.1995-08-15
PIPERACILIN TAZOBACTAM 4 UG (K953223)Ab Biodisk1995-08-15
ABBOTT TEST PACK STREP A TEST (K945571)Abbott Laboratories1995-08-14
RUBELLA IGG ELISA TEST (K941624)Gull Laboratories, Inc.1995-08-04
SAS SHIGELLA DYSENTERIAE TYPE 4 ANTISERUM (K953320)Sa Scientific, Inc.1995-08-04
SAS SHIGELLA DYSENTERIAE TYPE 5 ANTISERUM (K953319)Sa Scientific, Inc.1995-08-04
SAS SHIGELLA DYSENTERIAE GROUP A (1-7) ANTISERUM (K953316)Sa Scientific, Inc.1995-08-04
SAS SHIGELLA DYSENTERIAE TYPE 6 ANTISERUM (K953318)Sa Scientific, Inc.1995-08-04
SAS SHIGELLA DYSENTERIAE TYPE 7 ANTISERUM (K953317)Sa Scientific, Inc.1995-08-04
SAS SHIGELLA DYSENTERIAE TYPE 3 ANTISERUM (K953321)Sa Scientific, Inc.1995-08-04
SAS SHIGELLA BOYDII TYPE 2 ANTISERUM (K953323)Sa Scientific, Inc.1995-08-02
SAS SHIGELLA BOYDII TYPE 6 ANTISERUM (K953327)Sa Scientific, Inc.1995-08-02
SAS SHIGELLA BOYDII TYPE 5 ANTISERUM (K953326)Sa Scientific, Inc.1995-08-02
SAS SHIGELLA BOYDII TYPE 7 ANTISERUM (K953328)Sa Scientific, Inc.1995-08-02
SAS SHIGELLA BOYDII TYPE 1 ANTISERUM (K953322)Sa Scientific, Inc.1995-08-02
SAS SHIGELLA BOYDII GROUP C2 ANTISERUM (K953329)Sa Scientific, Inc.1995-08-02
SAS SHIGELLA BOYDII TYPE 4 ANTISERUM (K953325)Sa Scientific, Inc.1995-08-02
SAS SHIGELLA BOYDII TYPE 3 ANTISERUN (K953324)Sa Scientific, Inc.1995-08-02
ZEUA MYCOPLASMA (K944417)Zeus Scientific, Inc.1995-08-01
IMX TOXO IGG (K951636)Abbott Laboratories1995-08-01
SAS SALMONELLA H C ANTISERUM (K952288)Sa Scientific, Inc.1995-07-25
SAS BRUCELLAS ABORTUS ANTISERUM (K952146)Sa Scientific, Inc.1995-07-21
SAS BRUCELLA SUIS ANTISERUM (K952144)Sa Scientific, Inc.1995-07-21
SAS BRUCELLA MELITENSIS ANTISERUM (K952143)Sa Scientific, Inc.1995-07-21
SAS SALMONELLA H POLY POSITIVE ANTISERUM (K952134)Sa Scientific, Inc.1995-07-21
SAS FRANCISELLA TULARENSIS ANTISERUM (K952141)Sa Scientific, Inc.1995-07-21
EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY (K946353)Mrl Diagnostics1995-07-21
SAS SALMONELLA O POLY POSITIVE ANTISERUM (K952133)Sa Scientific, Inc.1995-07-21
SAS BRUCELLA AMS ANTISERUM (K952132)Sa Scientific, Inc.1995-07-21
DRIED GRAM-POSITIVE MIC/COMBO PANELS (K934458)Baxter Diagnostics, Inc.1995-07-18
SAS BRUCELLA SUIS ANTIGEN (K952139)Sa Scientific, Inc.1995-07-18
HM-CAP EIA KIT (K944159)Schiff & Co.1995-07-18
SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM (K952145)Sa Scientific, Inc.1995-07-18
SAS SALMONELLA H A ANTIGEN (K952137)Sa Scientific, Inc.1995-07-17
SAS FEBRILE ANTIGEN SET (K952131)Sa Scientific, Inc.1995-07-17
SAS SALMONELLA O GROUP D ANTIGEN (K952142)Sa Scientific, Inc.1995-07-17
SAS BRUCELLA MELTIENSIS ANTIGEN (K952140)Sa Scientific, Inc.1995-07-17
SAS BRUCELLA ABORTUS ANTIGEN (K952147)Sa Scientific, Inc.1995-07-17
SAS SALMONELLA H B ANTIGEN (K952136)Sa Scientific, Inc.1995-07-17
SAS FRANCISELLA TULARENSIS ANTIGEN (K952138)Sa Scientific, Inc.1995-07-17
SAS SALMONELLA H D ANTIGEN (K952135)Sa Scientific, Inc.1995-07-17
SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES (K936305)Radiometer America, Inc.1995-07-13
VISUWELL SYPHILIS ANTIBODY (K932453)Biomira Diagnostics, Inc.1995-07-11
TICARCILLIN/CLAVULANIC ACID 2 (K951879)Ab Biodisk1995-07-07
CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA (K950196)Bioclinical Systems, Inc.1995-06-30
CHOLERA SMART(TM) (K932622)New Horizons Diagnostics Co.1995-06-27
LMD GIARDIA ANTIGEN DETECTION ASSAY (K944871)Lmd Laboratories1995-06-22
TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT (K952246)Tri-Tech, Inc.1995-06-20
ENTEROCOCCUS SCREENING MEDIUM (K951539)Becton Dickinson Microbiology Systems1995-06-13
VIDAS LYME SCREEN II (K943812)Biomerieux Vitek, Inc.1995-06-13
SAS SALMONELLA H B ANTISERUM (K951069)Sa Scientific, Inc.1995-06-09
INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT (K946158)Incstar Corp.1995-06-09
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT (K946159)Incstar Corp.1995-06-07
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT (K946157)Incstar Corp.1995-06-07
STAPHAUREX PLUS(TM) (K945538)Murex Diagnostics Limitd1995-06-01
HEMAGEN CHAGAS' KIT (EIA METHOD) (K930272)Hemagen Diagnostics, Inc.1995-05-19
QUICKVUE(R) CHLAMYDIA TEST (K946276)Quidel Corp.1995-05-19
ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY (K935807)Bio-Rad Laboratories, Inc.1995-05-19
DRYSLIDE COAGULASE (K950706)Difco Laboratories, Inc.1995-05-16
LYFO(TM) DIFFERENTIAL DISK (K945488)Microbiologics, Inc.1995-05-11
LYFO(TM) DIFFERENTIAL DISK (K945489)Microbiologics, Inc.1995-05-11
LYFO(TM) DIFFERENTIAL DISK (K945487)Microbiologics, Inc.1995-05-11
PS II (K943513)Washington Biotechnology1995-05-11
B-L RED(TM) DISCS (K950346)Oxis Intl., Inc.1995-05-05
EBNA IGG ELISA TEST SYSTEM (K932742)Zeus Scientific, Inc.1995-05-05
E TEST FOR OFLOXACIN (K946364)Ab Biodisk1995-05-02
ELVIS HSV (K941924)Diagnostic Hybrids, Inc.1995-05-01
IMX(R) TOXO IGM (K945634)Abbott Laboratories1995-04-27
DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI (K950817)Baxter Diagnostics, Inc.1995-04-25
LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN (K945883)Microbiologics, Inc.1995-04-24
LYFO(TM) DIFFERENTIAL DISK-BILE (K945882)Microbiologics, Inc.1995-04-24
LYFO(TM) DIFFERENTIAL DISK-SPS (K945880)Microbiologics, Inc.1995-04-24
LYFO(TM) DIFFERENTIAL DISK-STERILE DISK (K945881)Microbiologics, Inc.1995-04-24
HP-FAST (K944903)Gi Supply1995-04-20
DRIED GRAM-NEGATIVE MIC//COMBO PANELS (K935704)Baxter Diagnostics, Inc.1995-04-14
PREMIER EHEC (K950167)Meridian Diagnostics, Inc.1995-04-14
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