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Microbiology

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

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RecordFirmDate
BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S002)Siemens Healthcare Diagnostics, Inc.2005-03-25
ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS (P040017)Bayer Healthcare, Diagnostics Division2005-03-07
VITROS IMMUNODIAGNOSTIC ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S005)Ortho-Clinical Diagnostics, Inc.2005-02-11
ABBOTT AXSYM ANTI-HCV (LIST NUMBER 5C36) (P970027/S004)Abbott Laboratories2005-01-31
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S004)Ortho-Clinical Diagnostics, Inc.2005-01-14
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS (P030026/S003)Ortho-Clinical Diagnostics, Inc.2005-01-04
ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS (P040004)Siemens Healthcare Diagnostics2004-12-22
ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS (P030056)Siemens Healthcare Diagnostics2004-12-22
ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS (P040018)Bayer Healthcare, LLC2004-12-22
BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S001)Siemens Healthcare Diagnostics, Inc.2004-12-14
DIGENE HYBRID CAPTURE HPV DNA TEST (P890064/S017)Qiagen Gaithersburg, Inc.2004-12-14
ABBOTT AXSYM ANTI-HCV (P970027/S003)Abbott Laboratories2004-12-14
HEPATITS C CHECK TEST SYSTEM (P980046/S007)Pwn Health Chicago, LLC2004-12-10
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR AND THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIR (P000044/S005)Ortho-Clinical Diagnostics, Inc.2004-12-08
AXSYM ANTI-HCV (P970027/S002)Abbott Laboratories2004-12-03
QUANTIFERON -TB GOLD (P010033/S006)Qiagen2004-12-02
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR (P030024/S002)Ortho-Clinical Diagnostics2004-11-04
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBSAG REAGENT PACK AND CALIBRATOR (P000044/S004)Ortho-Clinical Diagnostics, Inc.2004-11-04
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S002)Ortho-Clinical Diagnostics, Inc.2004-11-04
VITROS IMMUNODIAGNOSTIC ANTI-HBS REAGENT PACK AND CALIBRATOR (P000014/S010)Ortho-Clinical Diagnostics, Inc.2004-11-04
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR (P010021/S004)Ortho-Clinical Diagnostics, Inc.2004-11-04
COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S004)Roche Molecular Systems, Inc.2004-11-04
GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (P940034/S016)Gen-Probe, Inc.2004-10-08
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATS (P000014/S009)Ortho-Clinical Diagnostics, Inc.2004-09-27
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S003)Roche Molecular Systems, Inc.2004-08-30
ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS (P030040)Siemens Healthcare Diagnostics2004-08-06
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S003)Ortho-Clinical Diagnostics, Inc.2004-07-30
AXSYM HAVAB 2.0 (P780012/S014)Abbott Laboratories2004-07-30
DIGENE HYBRID CAPTURE 2 HPV DNA TEST (P890064/S015)Qiagen Gaithersburg, Inc.2004-07-29
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORS (P010021/S002)Ortho-Clinical Diagnostics, Inc.2004-07-16
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS (P000014/S008)Ortho-Clinical Diagnostics, Inc.2004-07-16
ABBOTT AXSYM ANTI-HCV (P970027/S001)Abbott Laboratories2004-06-30
AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST (P940040/S004)Roche Molecular Systems, Inc.2004-06-23
DEVICE: ABBOTT AXSYM HAVAB-M 2.0 (P790019/S018)Abbott Laboratories2004-06-16
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S001)Ortho-Clinical Diagnostics, Inc.2004-06-14
DIASORIN ETI-MAK-2 PLUS (P990038/S008)DiaSorin, Inc.2004-05-19
ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND CALIBRATORS (P030029)Siemens Healthcare Diagnostics2004-05-14
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS (P000014/S007)Ortho-Clinical Diagnostics, Inc.2004-05-14
AMPLICOR HCV TEST,VERSION 2.0 (P000010/S003)Roche Molecular Systems, Inc.2004-05-06
DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST (P890064/S014)Qiagen Gaithersburg, Inc.2004-05-04
DIASORIN ETI-MAK-2-PLUS (P990038/S006)DiaSorin, Inc.2004-05-03
DIASORIN ETI-CORE-IGMK PLUS (P990044/S005)DiaSorin, Inc.2004-04-30
DIASORIN ETI-MAK-2 PLUS (P990038/S007)DiaSorin, Inc.2004-04-30
DIASORIN ETI-EBK PLUS (P990043/S007)DiaSorin, Inc.2004-04-30
DIASORIN ETI-AB-EBK PLUS (P990041/S006)DiaSorin, Inc.2004-04-30
DIASORIN ETI-AB-AUK PLUS (P990042/S007)DiaSorin, Inc.2004-04-30
DIASORIN ETI-AB-COREK PLUS (P990045/S006)DiaSorin, Inc.2004-04-30
AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST (P940040/S003)Roche Molecular Systems, Inc.2004-04-22
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S001)Ortho-Clinical Diagnostics2004-04-02
DIASORIN ETI-EBK PLUS (P990043/S006)DiaSorin, Inc.2004-03-26
DIASORIN ETI-AB-EBK PLUS (P990041/S005)DiaSorin, Inc.2004-03-26
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR (P030026)Ortho-Clinical Diagnostics, Inc.2004-03-04
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR (P030024)Ortho-Clinical Diagnostics2004-03-04
DIASORIN ETI-AB-EBK PLUS ASSAY (P990041/S004)DiaSorin, Inc.2004-02-20
DIASORIN ETI-AB-HAVK PLUS ASSAY (P890019/S009)Diasorin2004-02-20
DIASORIN ETI-EBK PLUS ASSAY (P990043/S005)DiaSorin, Inc.2004-02-12
QUANTIFERON - TB (P010033/S007)Qiagen2004-02-10
GEN-PROBE ABPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (P940034/S015)Gen-Probe, Inc.2004-02-10
ABBOTT AXSYM ANTIBODY TO HCV (P970027)Abbott Laboratories2004-02-05
ABBOTT AXSYM HAVAB 2.0 (P780012/S009)Abbott Laboratories2004-02-02
ABBOTT AXSYM HAVAB-M 2.0 (P790019/S011)Abbott Laboratories2004-02-02
DIASORIN ETI-AB-COREK PLUS ASSAY (P990045/S005)DiaSorin, Inc.2003-11-26
HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND HYBRID CAPTURE HPV DNA TEST (P890064/S013)Qiagen Gaithersburg, Inc.2003-11-07
IMX HAVAB -M (LIST NUMBER 2263) (P790019/S017)Abbott Laboratories2003-11-06
HOME ACCESS HEPATITIS C CHECK TEST SERVICE (P980046/S006)Pwn Health Chicago, LLC2003-09-08
DIASORIN ETI-MAK-2 PLUS ASSAY (P990038/S005)DiaSorin, Inc.2003-08-20
QUANTIFERON-TB ANALYSIS SOFTWARE PROGRAM (P010033/S004)Qiagen2003-08-07
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS (P000014/S006)Ortho-Clinical Diagnostics, Inc.2003-07-09
ETI-AB-AUK PLUS (P990042/S006)DiaSorin, Inc.2003-06-30
ETI-CORE-IGMK PLUS (P990044/S003)DiaSorin, Inc.2003-06-26
ETI-AB-COREK PLUS (P990045/S004)DiaSorin, Inc.2003-06-26
ETI-EBK PLUS (P990043/S004)DiaSorin, Inc.2003-06-26
DIGENE HYBRID CAPTURE 2 HPV DNA TEST (P890064/S012)Qiagen Gaithersburg, Inc.2003-06-20
ETI-AB-EBK PLUS (P990041/S003)DiaSorin, Inc.2003-06-11
IMMULITE/ IMMULITE 1000 AND IMMULITE 2000 HBSAG KITS. (P010050/S003)Siemens Healthcare Diagnostics Products, Ltd.2003-06-11
QUANTIFERON-TB KIT (P010033/S005)Qiagen2003-05-12
DIASORIN ETI-CORE-IGMK PLUS (P990044/S004)DiaSorin, Inc.2003-05-07
DIASORIN ETI-HA-IGMK PLUS (P890014/S005)DiaSorin, Inc.2003-05-06
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS (P010021/S001)Ortho-Clinical Diagnostics, Inc.2003-04-30
DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST (P890064/S009)Qiagen Gaithersburg, Inc.2003-03-31
BAYER VERSANT (TM) HCV RNA 3.0 ASSAY (BDNA) (P020022)Siemens Healthcare Diagnostics, Inc.2003-03-28
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK/ CALIBRATOR (P000044/S003)Ortho-Clinical Diagnostics, Inc.2003-03-20
QUANTIFERON-TB (P010033/S003)Qiagen2003-03-17
DIASORIN HBSAG CONFIRMATORY TEST (P990038/S004)DiaSorin, Inc.2003-03-14
IMMULITE, IMMULITE 1000 ANTI-HBC AND IMMULITE 2000 ANTI-HBC (P010053/S001)Siemens Healthcare Diagnostics Products, Ltd.2003-03-13
IMMULITE, IMMULITE 1000 ANTI-HBS AND IMMULITE 2000 ANTI-HBS (P010052/S001)Siemens Healthcare Diagnostics Products, Ltd.2003-03-13
IMMULITE,IMMULITE 1000 HBSAG,CONFIRMATORY AND IMMULITE 2000 HBSAG,CONFIRMATORY KIT (P010050/S001)Siemens Healthcare Diagnostics Products, Ltd.2003-03-13
IMMULITE, IMMULITE 1000 ANTI-HBC IGM AND IMMULITE 2000 ANTI-HBCIGM (P010051/S001)Siemens Healthcare Diagnostics Products, Ltd.2003-03-13
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT/ANTI-HBS CALIBRATORS (P000014/S005)Ortho-Clinical Diagnostics, Inc.2003-02-24
ABBOTT HBE (RDNA) EIA (P790025/S008)Abbott Laboratories2003-01-17
BIOTRON PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY (P970054/S001)Diasorin2003-01-09
BIOTRON PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (P970055/S001)Diasorin2003-01-09
QUANTIFERON-TB (P010033/S002)Qiagen2002-12-17
HOME ACCESS HEPATITIS C TEST SERVICE (P980046/S005)Pwn Health Chicago, LLC2002-12-06
ETI-AB-AUK PLUS (P990042/S005)DiaSorin, Inc.2002-11-26
ETI-AB-AUK PLUS ASSAY (P990042/S004)DiaSorin, Inc.2002-11-14
ETI-AB-COREK PLUS (P990045/S003)DiaSorin, Inc.2002-11-08
ETI-HA-IGMK PLUS KIT (P890014/S004)DiaSorin, Inc.2002-11-08
DIASORIN ETI-MAK-2 PLUS (P990038/S003)DiaSorin, Inc.2002-11-08
DIASORIN ETI-AB-HAVK PLUS (P890019/S007)Diasorin2002-11-08
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