Atlas FDA

Microbiology

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

Sort:Newest firstOldest first

◉ Watch Microbiology

RecordFirmDate
BIO RAD MONOLISA ANTI-HBC IGM EIA (P060034)Bio-Rad Laboratories, Inc.2007-05-31
BIO-RAD MONOLISA ANTI-HBC EIA (P060031)Bio-Rad Laboratories, Inc.2007-04-27
VITROS IMMUNODIAGNOSTIC PRODUCTS HCV REAGENT PACK & CALIBRATOR (P010021/S010)Ortho-Clinical Diagnostics, Inc.2007-04-16
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR & CONFIRMATORY KIT (P000044/S016)Ortho-Clinical Diagnostics, Inc.2007-04-16
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S013)Ortho-Clinical Diagnostics, Inc.2007-04-06
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR & CONFIRMATORY KIT (P000044/S015)Ortho-Clinical Diagnostics, Inc.2007-03-27
ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS (P010054/S001)Roche Diagnostics Corp.2007-03-13
ROCHE ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFORMATORY TEST AND PRECICONTROL HBSAG (P990012/S001)Roche Diagnostics Corp.2007-03-13
ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS (P010054/S003)Roche Diagnostics Corp.2007-03-13
ARCHITECT ANTI-HCV (P050042/S002)Abbott Laboratories, Inc.2007-03-05
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S012)Ortho-Clinical Diagnostics, Inc.2007-03-05
COBAS AMPLICOR HEPTATIS C VIRUS (HCV) TEST (P000012/S012)Roche Molecular Systems, Inc.2007-02-28
AXSYM CORE-M 2.0 & AXSYM CORE-M 2.0 CONTROLS (P060009/S001)Abbott Laboratories, Inc.2007-02-05
AXSYM ANTIBODY TO HCV (P970027/S005)Abbott Laboratories2007-02-05
AXSYM AUSAB (P060003/S003)Abbott Laboratories, Inc.2007-02-05
AXSYM CORE 2.0 & AXSYM CORE 2.0 CONTROLS (P060012/S001)Abbott Laboratories, Inc.2007-02-05
ABBOTT AXSYM HBSAG ASSAY (P050049/S001)Abbott Laboratories, Inc.2007-02-05
DIASORIN ETI-AB-EBK PLUS (P990041/S009)DiaSorin, Inc.2007-01-19
DIASORIN ETI-EBK PLUS (P990043/S010)DiaSorin, Inc.2007-01-19
DIASORIN ETI-CORE-IGMK PLUS (P990044/S008)DiaSorin, Inc.2007-01-19
ARCHITECT HBSAG AND HBSAG CONFIRMATORY (P060007/S001)Abbott Laboratories2006-10-18
ABBOTT AXSYM AUSAB (P060003/S002)Abbott Laboratories, Inc.2006-10-04
VITROS IMMUNODIAGNOSTIC PRODUCT ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S011)Ortho-Clinical Diagnostics, Inc.2006-09-12
ABBOTT AXSYM AUSAB (P060003/S001)Abbott Laboratories, Inc.2006-09-11
AXSYM CORE 2.0 AND AXSYM CORE 2.0 CONTROLS (P060012)Abbott Laboratories, Inc.2006-09-08
ARCHITECT HBSAG REAGENT KIT, CALIBRATORS, CONTROLS, CONFIRMATORY REAGENT KIT, CONFIRMATORY MANUAL DILUENT (P060007)Abbott Laboratories2006-09-07
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK, CALIBRATOR, CONFIRMATORY KIT (P000044/S014)Ortho-Clinical Diagnostics, Inc.2006-09-06
IMMULITE / IMMULITE 1000 HBSAG & IMMULITE 2000 HBSAG (P010050/S005)Siemens Healthcare Diagnostics Products, Ltd.2006-09-01
AXSYM CORE-M 2.0 AND AXSYM CORE-M 2.0 CONTROLS (P060009)Abbott Laboratories, Inc.2006-08-25
MONOLISA ANTI-HBS EIA (P050048)Bio-Rad Laboratories2006-08-25
ARCHITECT ANTI-HCV REAGENT KITS, ARCHITECT ANTI-HCV CALIBRATORS, AND ARCHITECT ANTI-HCV CONTROLS (P050042/S001)Abbott Laboratories, Inc.2006-08-14
AXSYM, AUSAB (P060003)Abbott Laboratories, Inc.2006-08-07
ARCHITECT AUSAB REAGENT KIT, ARCHITECT AUSAB CALIBRATORS, ARCHITECT AUSAB CONTROLS (P050051/S001)Abbott Laboratories, Inc.2006-08-07
ELECSYS ANTI-HBS IMMUNOASSAY TEST SYSTEM (P010054/S005)Roche Diagnostics Corp.2006-07-28
QUANTIFERON -TB GOLD (P010033/S009)Qiagen2006-07-26
VITROS IMMUNODIAGNOSTIC HBSAG REAGENT PACK CALIBRATOR AND CONFIRMATORY KIT (P000044/S013)Ortho-Clinical Diagnostics, Inc.2006-07-14
ELECSYS AND HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS (P010054/S004)Roche Diagnostics Corp.2006-06-30
AMPLICOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.0 (P000010/S007)Roche Molecular Systems, Inc.2006-06-22
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC ASSAYS (P010051/S004)Siemens Healthcare Diagnostics Products, Ltd.2006-06-16
COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, V2.0 (P000012/S009)Roche Molecular Systems, Inc.2006-06-16
ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL (P050042)Abbott Laboratories, Inc.2006-06-07
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR & PRODUCTS HBSAG CONFIRMATORY KIT (P000044/S012)Ortho-Clinical Diagnostics, Inc.2006-06-05
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S010)Ortho-Clinical Diagnostics, Inc.2006-06-05
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATOR (P000014/S014)Ortho-Clinical Diagnostics, Inc.2006-06-05
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S005)Ortho-Clinical Diagnostics2006-06-05
ABBOTT ARCHITECT AUSAB (P050051)Abbott Laboratories, Inc.2006-06-01
AXSYM HBSAG, HBSAG CONFIRMATORY, AND AXSYM HBSAG CONTROLS (P050049)Abbott Laboratories, Inc.2006-06-01
DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 HPV DNA TEST (P890064/S018)Qiagen Gaithersburg, Inc.2006-04-28
ETI-MAK-2 PLUS (P990038/S011)DiaSorin, Inc.2006-04-19
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR, AND HBSAG CONFIRMATORY KIT (P000044/S011)Ortho-Clinical Diagnostics, Inc.2006-04-03
QUANTIFERON-TB GOLD (P010033/S010)Qiagen2006-03-10
BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S004)Siemens Healthcare Diagnostics, Inc.2006-03-03
COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSION 2.0 (P000012/S007)Roche Molecular Systems, Inc.2006-02-17
AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSION 2.0 (P000010/S006)Roche Molecular Systems, Inc.2006-02-17
BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S003)Siemens Healthcare Diagnostics, Inc.2006-02-17
AMPLICOR HCV TEST, V2.0 (P000010/S005)Roche Molecular Systems, Inc.2006-01-25
COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S006)Roche Molecular Systems, Inc.2006-01-25
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S008)Roche Molecular Systems, Inc.2006-01-25
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S007)Ortho-Clinical Diagnostics, Inc.2006-01-12
AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST (P940040/S006)Roche Molecular Systems, Inc.2005-12-14
ETI-HA-IGMK PLUS KIT (P890014/S008)DiaSorin, Inc.2005-12-14
ETI-AB-HAVK PLUS (P890019/S012)Diasorin2005-12-12
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S004)Ortho-Clinical Diagnostics2005-12-08
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S008)Ortho-Clinical Diagnostics, Inc.2005-12-08
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR (P000044/S010)Ortho-Clinical Diagnostics, Inc.2005-12-08
IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATOR (P000014/S013)Ortho-Clinical Diagnostics, Inc.2005-12-08
VITROS IMMUNODIAGNOSTIC PRODICTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S009)Ortho-Clinical Diagnostics, Inc.2005-12-08
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATORS (P000044/S009)Ortho-Clinical Diagnostics, Inc.2005-11-17
ELECSYS HBSAG TEST SYSTEM (P990012/S003)Roche Diagnostics Corp.2005-11-09
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC (P010051/S003)Siemens Healthcare Diagnostics Products, Ltd.2005-11-02
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS (P010052/S003)Siemens Healthcare Diagnostics Products, Ltd.2005-11-02
IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC IGM (P010053/S003)Siemens Healthcare Diagnostics Products, Ltd.2005-11-02
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S008)Ortho-Clinical Diagnostics, Inc.2005-10-21
ABBOTT IMX HAVAB-M LIST 2263 (P790019/S020)Abbott Laboratories2005-10-06
ELECSYS ANTI-HBS,ELECSYS PRECICONTROL ANTI-HBS (P010054/S002)Roche Diagnostics Corp.2005-10-06
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATORS (P000044/S008)Ortho-Clinical Diagnostics, Inc.2005-09-22
ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY TEST AND ELECSYS PRECICONTROL HBSAG (P990012/S002)Roche Diagnostics Corp.2005-09-22
ETI-AB-COREK PLUS (P990045/S008)DiaSorin, Inc.2005-08-29
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S006)Ortho-Clinical Diagnostics, Inc.2005-08-11
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR/CONFIRMATORY KIT (P000044/S007)Ortho-Clinical Diagnostics, Inc.2005-08-08
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATORS (P030026/S007)Ortho-Clinical Diagnostics, Inc.2005-07-18
DIASORIN ETI-HA-IGMK PLUS (P890014/S007)DiaSorin, Inc.2005-06-22
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS (P030026/S006)Ortho-Clinical Diagnostics, Inc.2005-06-22
DIASORIN ETI-AB-HAVK PLUS (P890019/S011)Diasorin2005-06-22
DIASORIN ETI-MAK-2PLUS (P990038/S010)DiaSorin, Inc.2005-06-22
DIASORIN ETI-EBK PLUS (P990043/S009)DiaSorin, Inc.2005-06-22
DIASORIN ETI-AB-EBK PLUS (P990041/S008)DiaSorin, Inc.2005-06-22
DIASORIN ETI-CORE-IGMK PLUS (P990044/S007)DiaSorin, Inc.2005-06-22
ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL MATERIAL (P030049)Siemens Healthcare Diagnostics2005-05-26
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS (P000014/S012)Ortho-Clinical Diagnostics, Inc.2005-05-25
ABBOTT HAVAB -M EIA (P790019/S019)Abbott Laboratories2005-05-25
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S003)Ortho-Clinical Diagnostics2005-05-05
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR AND THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIR (P000044/S006)Ortho-Clinical Diagnostics, Inc.2005-05-05
AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST (P940040/S005)Roche Molecular Systems, Inc.2005-04-22
AMPLICOR HCV, TEST VERSION 2.0 (P000010/S004)Roche Molecular Systems, Inc.2005-04-22
COBAS AMPLICOR HCV TEST, VERSION 2.0 AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S005)Roche Molecular Systems, Inc.2005-04-22
VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS (P030026/S005)Ortho-Clinical Diagnostics, Inc.2005-04-15
PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY (P970054/S002)Diasorin2005-04-01
PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (P970055/S002)Diasorin2005-04-01
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HB REAGENT PACK & CALIBRATORS (P000014/S011)Ortho-Clinical Diagnostics, Inc.2005-03-29
← Previous Next →

Track Microbiology automatically

Every clearance here is in the API, with alerts when new ones post.