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Microbiology

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

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RecordFirmDate
ADVIA CENTAUR HBSAG READYPACK REAGENTS / CONFIRMATORY ASSAY/ QUALITY CONTROL MATERIAL (P030049/S004)Siemens Healthcare Diagnostics2009-04-09
ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/TOTAL QUALITY CONTROL MATERIALS (P040004/S004)Siemens Healthcare Diagnostics2009-04-09
ADVIA CENTAUR HCV READYPACK REAGENNTS/QUALITY CONTROL MATERIALS (P030056/S004)Siemens Healthcare Diagnostics2009-04-09
ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS & CALIBRATORS & CONTROL MATERIAL (P030029/S005)Siemens Healthcare Diagnostics2009-04-09
ADVIA CENTAUR HBC IGM READYPACK REAGENTS/QUALITY CONTROL MATERIALS (P030040/S004)Siemens Healthcare Diagnostics2009-04-09
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK & CALIBRATORS (P000014/S018)Ortho-Clinical Diagnostics, Inc.2009-03-19
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATORS (P000044/S021)Ortho-Clinical Diagnostics, Inc.2009-03-19
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATORS (P030024/S011)Ortho-Clinical Diagnostics2009-03-19
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS (P010021/S015)Ortho-Clinical Diagnostics, Inc.2009-03-19
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATORS (P030026/S017)Ortho-Clinical Diagnostics, Inc.2009-03-19
CERVISTA HPV 16/18 (P080015)Hologic, Inc.2009-03-12
CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT (P080014)Hologic, Inc.2009-03-12
ABBOTT AXSYM AUSAB (P060003/S004)Abbott Laboratories, Inc.2009-03-05
ADVIA CENTAUR HBCIGM (P030040/S003)Siemens Healthcare Diagnostics2009-03-04
ADVIA CENTAUR HCV (P030056/S003)Siemens Healthcare Diagnostics2009-03-04
ADVIA CENTAUR HBSAG (P030049/S003)Siemens Healthcare Diagnostics2009-03-04
ADVIA CENTAUR HBCT (P040004/S003)Siemens Healthcare Diagnostics2009-03-04
BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM IN VITRO DIAGNOSTIC DEVICE (P970055/S007)Diasorin2009-03-03
BIOTRIN INTERNATIONALS PARVOVIRUS B19 IGG IN VITRO DIAGNOSTIC DEVICE (P970054/S007)Diasorin2009-03-03
ETI-EBK PLUS KIT (P990043/S011)DiaSorin, Inc.2009-02-25
BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S002)Bio-Rad Laboratories, Inc.2009-02-25
ETI-AB-EBK PLUS KIT (P990041/S010)DiaSorin, Inc.2009-02-25
BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S002)Bio-Rad Laboratories, Inc.2009-02-20
IMMULITE & IMMULITE 2000 HBSAG ASSAY (P010050/S007)Siemens Healthcare Diagnostics Products, Ltd.2009-02-09
ABBOTT ARCHITECT ANTI-HCV (P050042/S004)Abbott Laboratories, Inc.2009-01-28
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR (P000044/S019)Ortho-Clinical Diagnostics, Inc.2009-01-14
VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR (P030024/S009)Ortho-Clinical Diagnostics2009-01-14
COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S020)Roche Molecular Systems, Inc.2009-01-14
VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S015)Ortho-Clinical Diagnostics, Inc.2009-01-14
AMPLICOR HCV TEST VERSION 2.0 (P000010/S013)Roche Molecular Systems, Inc.2009-01-14
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR (P000014/S017)Ortho-Clinical Diagnostics, Inc.2009-01-14
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR (P010021/S014)Ortho-Clinical Diagnostics, Inc.2009-01-14
COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM (P050028/S003)Roche Molecular Systems, Inc.2008-12-22
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S019)Roche Molecular Systems, Inc.2008-12-22
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S002)Roche Molecular Systems, Inc.2008-12-22
AXSYM HBSAG, AXSYM HBSAG CONFIRMATORY AND AXSYM HBSAG CONTROLS (P050049/S003)Abbott Laboratories, Inc.2008-12-17
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS (P010052/S005)Siemens Healthcare Diagnostics Products, Ltd.2008-12-16
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC IGM (P010053/S004)Siemens Healthcare Diagnostics Products, Ltd.2008-12-16
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC (P010051/S005)Siemens Healthcare Diagnostics Products, Ltd.2008-12-16
IMMULITE/IMMULITE 1000, IMMULITE 2000 HBSAG/HBSAG CONFIMATORY (P010050/S006)Siemens Healthcare Diagnostics Products, Ltd.2008-12-16
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S001)Roche Molecular Systems, Inc.2008-12-04
ROCHE MOLECULAR SYSTEMS COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S018)Roche Molecular Systems, Inc.2008-12-04
COBAS TAQMAN HBV TEST (P050028/S002)Roche Molecular Systems, Inc.2008-11-25
AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST (P940040/S010)Roche Molecular Systems, Inc.2008-11-25
ELECSYS HBSAG TEST SYSTEM (P990012/S005)Roche Diagnostics Corp.2008-11-13
ELECSYS ANTI-HBS TEST SYSTEM (P010054/S007)Roche Diagnostics Corp.2008-11-13
ABBOTT ARCHITECT AUSAB (P050051/S003)Abbott Laboratories, Inc.2008-11-13
COBAS TAQMAN HBV TEST (P050028/S001)Roche Molecular Systems, Inc.2008-11-12
QUANTIFERON - TB GOLD-IN-TUBE (P010033/S013)Qiagen2008-10-31
ELECSYS HBSAG TEST SYSTEM (P990012/S006)Roche Diagnostics Corp.2008-10-30
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030)Roche Molecular Systems, Inc.2008-10-30
ELECSYS ANTI-HBS TEST SYSTEM (P010054/S008)Roche Diagnostics Corp.2008-10-30
BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S001)Bio-Rad Laboratories, Inc.2008-10-09
BIO-RAD MONOLOSA ANTI-HBC EIA (P060031/S001)Bio-Rad Laboratories, Inc.2008-10-09
ELECSYS HBSAG IMMUNOASSAY (P990012/S007)Roche Diagnostics Corp.2008-09-23
ELECSYS ANTI-HBS IMMUNOASSAY (P010054/S010)Roche Diagnostics Corp.2008-09-23
COBAS TAQMAN HBV TEST (P050028)Roche Molecular Systems, Inc.2008-09-04
AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST (P940040/S009)Roche Molecular Systems, Inc.2008-08-26
AMPLICOR HCV TEST (P000010/S012)Roche Molecular Systems, Inc.2008-08-26
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S017)Roche Molecular Systems, Inc.2008-08-26
COBAS AMPLICOR HCV TEST (P000012/S016)Roche Molecular Systems, Inc.2008-08-26
T SPOT-TB TEST (P070006)Oxford Immunotec, Ltd.2008-07-30
BIO-RAD MONOLISA ANTI-HBS EIA & ANTI-HBS CALIBRATOR KIT (P050048/S001)Bio-Rad Laboratories2008-07-17
ELECSYS ANTI-HBS CALCHECK (P010054/S009)Roche Diagnostics Corp.2008-07-09
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR, HBSAG CONFIRMATORY ASSAY (P000044/S018)Ortho-Clinical Diagnostics, Inc.2008-06-12
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S013)Ortho-Clinical Diagnostics, Inc.2008-04-16
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATORS (P030026/S014)Ortho-Clinical Diagnostics, Inc.2008-03-05
ABBOTT AXSYM ANTI-HCV (P970027/S006)Abbott Laboratories2008-02-22
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR (P000044/S017)Ortho-Clinical Diagnostics, Inc.2008-02-20
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS (P010021/S012)Ortho-Clinical Diagnostics, Inc.2008-02-20
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATORS (P030024/S008)Ortho-Clinical Diagnostics2008-02-20
VITROS IMMUNDIAGNOSTICS PRODUCTS ANTI HB-S QUANTITATIVE REAGENT PACK & CALIBRATORS (P000014/S016)Ortho-Clinical Diagnostics, Inc.2008-02-20
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S007)Ortho-Clinical Diagnostics2008-02-12
COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S014)Roche Molecular Systems, Inc.2008-02-06
AMPLICOR HCV TEST, VERSION 2.0 (P000010/S010)Roche Molecular Systems, Inc.2008-02-06
AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST (P940040/S008)Roche Molecular Systems, Inc.2008-01-11
COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST (P000012/S015)Roche Molecular Systems, Inc.2008-01-11
AMPLICOR HEPATITIS C VIRUS (HCV) TEST (P000010/S011)Roche Molecular Systems, Inc.2008-01-11
ABBOTT AXSYM HBSAG (P050049/S002)Abbott Laboratories, Inc.2007-12-19
VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S006)Siemens Healthcare Diagnostics, Inc.2007-12-14
ABBOTT ARCHITECT ANTI-HCV (P050042/S003)Abbott Laboratories, Inc.2007-12-10
ABBOTT ARCHITECT (P050051/S002)Abbott Laboratories, Inc.2007-12-05
QUANTIFERON TB GOLD (P010033/S012)Qiagen2007-11-28
ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS (P060035)Abbott Laboratories2007-11-06
QUANTIFERON TB GOLD IN TUBE (P010033/S011)Qiagen2007-10-10
PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (P970055/S005)Diasorin2007-10-10
PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY (P970054/S005)Diasorin2007-10-10
COBAS AMPLICOR HCV TEST VERSION 2.0 (P000012/S013)Roche Molecular Systems, Inc.2007-08-30
AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST (P940040/S007)Roche Molecular Systems, Inc.2007-08-30
AMPLICOR HCV TEST VERSION 2.0 (P000010/S009)Roche Molecular Systems, Inc.2007-08-30
PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (P970055/S006)Diasorin2007-08-24
PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY (P970054/S006)Diasorin2007-08-24
ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS & CALIBRATORS (P030029/S001)Siemens Healthcare Diagnostics2007-08-02
BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S005)Siemens Healthcare Diagnostics, Inc.2007-08-01
GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD) (P940034/S017)Gen-Probe, Inc.2007-07-18
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR (P010021/S011)Ortho-Clinical Diagnostics, Inc.2007-06-21
IGM ENZYME IMMUNOASSAY (P970055/S004)Diasorin2007-06-08
IGG ENZYME IMMUNOASSAY (P970054/S004)Diasorin2007-06-08
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR (P000014/S015)Ortho-Clinical Diagnostics, Inc.2007-06-06
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR (P030024/S006)Ortho-Clinical Diagnostics2007-06-06
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Every clearance here is in the API, with alerts when new ones post.