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Microbiology

3,049 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S005)Bio-Rad Laboratories, Inc.2011-04-28
BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S004)Bio-Rad Laboratories2011-04-25
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S021)Ortho-Clinical Diagnostics, Inc.2011-04-22
ABBOTT ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS (P060007/S012)Abbott Laboratories2011-04-21
AXSYM CORE 2.0 (P060012/S007)Abbott Laboratories, Inc.2011-04-21
DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGENE HYBRID CAPTURE CAPTURE 2 (HC2) HIGH HPV DNA TEST (P890064/S026)Qiagen Gaithersburg, Inc.2011-04-20
COBAS HPV TEST (P100020)Roche Molecular Systems, Inc.2011-04-19
AXSYM ANTI-HCV (P970027/S013)Abbott Laboratories2011-04-15
AXSYM HBSAG/CONFIRMATORY (P050049/S006)Abbott Laboratories, Inc.2011-04-15
AXSYM CORE 2.0 (P060012/S006)Abbott Laboratories, Inc.2011-04-15
AXSYM AUSAB (P060003/S008)Abbott Laboratories, Inc.2011-04-15
AXSYM CORE-M 2.0 (P060009/S004)Abbott Laboratories, Inc.2011-04-15
ARCHITECT AUSAB (P050051/S007)Abbott Laboratories, Inc.2011-04-04
ABBOTT ARCHITECT HBSAG AND ARCHITECT HBSAG CONFIRMATORY (P060007/S004)Abbott Laboratories2011-04-04
AXSYM CORE-M 2.0 (P060009/S005)Abbott Laboratories, Inc.2011-04-04
ARCHITECT AUSAB (P050051/S005)Abbott Laboratories, Inc.2011-04-04
ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS (P060007/S009)Abbott Laboratories2011-03-30
ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS (P060007/S011)Abbott Laboratories2011-03-30
ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS (P060007/S010)Abbott Laboratories2011-03-30
ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS (P060007/S008)Abbott Laboratories2011-03-30
CERVISTA HPV HR (P080014/S005)Hologic, Inc.2011-03-29
CERVISTA HPV 16/18 (P080015/S002)Hologic, Inc.2011-03-29
DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & HIGH RISK HPV DNA TEST (P890064/S025)Qiagen Gaithersburg, Inc.2011-03-29
ABBOTT ARCHITECT AUSAB (P050051/S010)Abbott Laboratories, Inc.2011-03-23
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S017)Roche Molecular Systems, Inc.2011-03-22
ARCHITECT AUSAB (P050051/S009)Abbott Laboratories, Inc.2011-03-22
AMPLICOR HCV TEST V2.0/COBAS AMPLICOR HCV TEST V2.0 (P000010/S020)Roche Molecular Systems, Inc.2011-03-22
ARCHITECT CORE-M (P060035/S006)Abbott Laboratories2011-03-22
ARCHITECT HBSAG/CONFIRMATORY (P060007/S007)Abbott Laboratories2011-03-22
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST V2.0 (P000012/S029)Roche Molecular Systems, Inc.2011-03-22
ARCHITECT ANTI-HCV (P050042/S010)Abbott Laboratories, Inc.2011-03-22
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 (P050028/S016)Roche Molecular Systems, Inc.2011-03-22
ARCHITECT CORE (P080023/S006)Abbott Laboratories2011-03-22
ADVIA CENTAUR ANTI-HBS ASSAY (P030029/S012)Siemens Healthcare Diagnostics2011-03-14
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR (P000014/S023)Ortho-Clinical Diagnostics, Inc.2011-03-10
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S014)Ortho-Clinical Diagnostics2011-02-28
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S013)Roche Molecular Systems, Inc.2011-02-24
COBAS TAQMAN HCV TEST V2.0 FOR USE WITH THE HIGH PURE SYSTEM (P060030/S015)Roche Molecular Systems, Inc.2011-02-24
ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S001)OraSure Technologies, Inc.2011-02-18
ARCHITECT ANTI-HCV (P050042/S009)Abbott Laboratories, Inc.2011-02-17
CERVISTA (P080015/S003)Hologic, Inc.2011-02-03
CERVISTA HPV HR TEST (P080014/S006)Hologic, Inc.2011-01-20
ARCHITECT HBSAG/CONFIRMATORY (P060007/S006)Abbott Laboratories2011-01-14
ARCHITECT CORE (P080023/S004)Abbott Laboratories2011-01-14
ETI-MAX 3000 ANALYZER (P990042/S008)DiaSorin, Inc.2011-01-14
ARCHITECT CORE-M (P060035/S004)Abbott Laboratories2011-01-14
ARCHITECT AUSAB (P050051/S008)Abbott Laboratories, Inc.2011-01-14
ARCHITECT ANTI-HCV (P050042/S008)Abbott Laboratories, Inc.2011-01-14
AXSYM ANTI-HCV (P970027/S012)Abbott Laboratories2011-01-05
ARCHITECT CORE-M (P060035/S002)Abbott Laboratories2011-01-04
ABBOTT ARCHITECT ANTI-HCV (P050042/S006)Abbott Laboratories, Inc.2011-01-04
ARCHITECH CORE (P080023/S002)Abbott Laboratories2011-01-04
BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S003)Bio-Rad Laboratories, Inc.2010-12-30
QUANTIFERON-TB GOLD IN-TUBE (P010033/S016)Qiagen2010-12-17
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S028)Roche Molecular Systems, Inc.2010-12-10
AMPLICOR HCV/COBAS AMPLICOR HCV TEST (P000010/S018)Roche Molecular Systems, Inc.2010-12-10
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V.2.0 (P050028/S012)Roche Molecular Systems, Inc.2010-12-07
MONOLISA ANTI-HBC IGM EIA (P060034/S005)Bio-Rad Laboratories, Inc.2010-11-23
MONOLISA ANTI-HBC EIA (P060031/S004)Bio-Rad Laboratories, Inc.2010-11-23
MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT (P050048/S005)Bio-Rad Laboratories2010-11-23
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR (P030024/S013)Ortho-Clinical Diagnostics2010-11-16
VITROS IMMUNDIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S020)Ortho-Clinical Diagnostics, Inc.2010-11-16
VITROS IMMUNODIAGNOSTICS HBSAG REAGENT PACK & CALIBRATOR (P000044/S025)Ortho-Clinical Diagnostics, Inc.2010-11-16
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR (P000014/S022)Ortho-Clinical Diagnostics, Inc.2010-11-16
CERVISTA HPV HR (P080014/S004)Hologic, Inc.2010-10-26
AXSYM CORE 2.0 (P060012/S003)Abbott Laboratories, Inc.2010-10-20
AXSYM HBSAG/CONFIRMATORY (LN 9B01) (P050049/S004)Abbott Laboratories, Inc.2010-10-19
AXSYM ANTI-HCV (LN 5C36) (P970027/S010)Abbott Laboratories2010-10-19
AXSYM AUSAB (LN 3C74) (P060003/S006)Abbott Laboratories, Inc.2010-10-19
AXSYM CORE-M 2.0 (LN 8B89) (P060009/S002)Abbott Laboratories, Inc.2010-10-19
AXSYM CORE 2.0 (LN 8B88) (P060012/S004)Abbott Laboratories, Inc.2010-10-19
ADVIA ANTI-HBS ASSAY (P030029/S011)Siemens Healthcare Diagnostics2010-10-18
CERVISTA HPV HR AND DNA EXTENSION KIT (P080014/S003)Hologic, Inc.2010-10-06
BIO-RAD MONOLISA ANTI -HBS EIA (P050048/S006)Bio-Rad Laboratories2010-09-27
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE ROCHE COBAS E 411 IMMUNOASSAY ANALYZER (P090007/S001)Roche Diagnostics Corp.2010-09-23
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZER (P090009/S001)Roche Diagnostics Corp.2010-09-23
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE ROCHE COBAS E 601 IMMUNOASSAY ANALYZER (P090008/S001)Roche Diagnostics Corp.2010-09-23
AMPLICOR HCV TEST (P000010/S017)Roche Molecular Systems, Inc.2010-09-23
COBAS AMPLIPREP/COBAS AMPLICOR HVC TEST (P000012/S025)Roche Molecular Systems, Inc.2010-09-23
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S014)Roche Molecular Systems, Inc.2010-09-22
AXSYM ANTI-HCV (P970027/S009)Abbott Laboratories2010-09-20
VERSANT & APTIMA HCV RNA QUALITATIVE ASSAY (P020011/S002)Gen-Probe2010-09-17
VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY (P020011/S004)Gen-Probe2010-09-17
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S004)Roche Molecular Systems, Inc.2010-09-09
COBAS TAQMAN HCV TEST VERSION 2.0 (P060030/S006)Roche Molecular Systems, Inc.2010-09-01
ADVIA CENTAUR ANTI-HBS (AHBS) (P030029/S009)Siemens Healthcare Diagnostics2010-09-01
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S012)Roche Molecular Systems, Inc.2010-08-30
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR; HBSAG CONFIRMATORY KIT (P000044/S024)Ortho-Clinical Diagnostics, Inc.2010-08-30
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S008)Roche Molecular Systems, Inc.2010-08-30
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR (P000014/S021)Ortho-Clinical Diagnostics, Inc.2010-08-19
ABBOTT REALTIME HBV ASSAY (P080026)Abbott Molecular, Inc.2010-08-13
BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S004)Bio-Rad Laboratories, Inc.2010-08-02
ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S012)Ortho-Clinical Diagnostics2010-07-16
HBSAG REAGENT PACK/CALIBRATOR & CONFIRMATORY KIT (P000044/S023)Ortho-Clinical Diagnostics, Inc.2010-07-16
ANTI-HBC REAGENT PACK AND CALIBRATOR (P030026/S019)Ortho-Clinical Diagnostics, Inc.2010-07-16
ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S017)Ortho-Clinical Diagnostics, Inc.2010-07-16
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATOR (P000014/S020)Ortho-Clinical Diagnostics, Inc.2010-07-16
T-SPOT TB TEST (P070006/S001)Oxford Immunotec, Ltd.2010-07-09
CERVISTA HPV HR (P080014/S002)Hologic, Inc.2010-06-28
CERVISTA HPV 16/18 (P080015/S001)Hologic, Inc.2010-06-28
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