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Microbiology

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

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RecordFirmDate
PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (V619IMUD) (P970055/S013)Diasorin2013-12-23
VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S010)Siemens Healthcare Diagnostics, Inc.2013-12-23
PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY (P970054/S010)Diasorin2013-12-23
ELECSYS ANTI-HBC TEST SYSTEM (P100031/S008)Roche Diagnostics Corp.2013-12-20
ELECSYS ANTI-HBC TEST SYSTEM (P100032/S007)Roche Diagnostics Corp.2013-12-19
ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S015)OraSure Technologies, Inc.2013-12-17
COBAS HPV TEST, 240 TESTS; COBAS HPV TEST 960 TESTS (P100020/S012)Roche Molecular Systems, Inc.2013-12-16
BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S007)Bio-Rad Laboratories, Inc.2013-12-12
BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S009)Bio-Rad Laboratories2013-12-12
BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S007)Bio-Rad Laboratories, Inc.2013-12-12
ABBOTT REALTIME HBV ASSAY (P080026/S011)Abbott Molecular, Inc.2013-12-11
ABBOTT REALTIME HCV ASSAY (P100017/S009)Abbott Molecular, Inc.2013-12-11
CERVISTA HPV HR (P080014/S020)Hologic, Inc.2013-12-03
CERVISTA HPV 16/18 (P080015/S011)Hologic, Inc.2013-12-03
ARCHITECT CORE (P080023/S023)Abbott Laboratories2013-11-26
ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY (P110029/S014)Abbott Laboratories2013-11-26
ARCHITECT CORE (P080023/S024)Abbott Laboratories2013-11-26
ARCHITECT ANTI-HCV (P050042/S028)Abbott Laboratories, Inc.2013-11-26
ARCHITECT AUSAB (P050051/S023)Abbott Laboratories, Inc.2013-11-26
ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY (P110029/S016)Abbott Laboratories2013-11-26
COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST (P110037/S012)Roche Molecular Systems, Inc.2013-11-26
ARCHITECT HBSAG QUAL/CONF (P110029/S015)Abbott Laboratories2013-11-26
ARCHITECT AUSAB (P050051/S024)Abbott Laboratories, Inc.2013-11-26
ARCHITECT CORE-M (P060035/S021)Abbott Laboratories2013-11-26
ARCHITECT ANTI-HCV (P050042/S027)Abbott Laboratories, Inc.2013-11-26
ARCHITECT CORE-M (P060035/S022)Abbott Laboratories2013-11-26
ABBOTT REAL TIME HBV CALIBRATOR KIT (P100017/S008)Abbott Molecular, Inc.2013-11-19
ABBOTT REAL TIME HBV CONTROL KIT (P080026/S010)Abbott Molecular, Inc.2013-11-19
ARCHITECT ANTI-HCV ASSAY, LN IL79 (P050042/S026)Abbott Laboratories, Inc.2013-11-15
APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007/S001)Gen-Probe Incorporated2013-11-06
ARCHITECT HBSAG QUALITATIVE CONFIRMATORY , LN 4P54 (P110029/S013)Abbott Laboratories2013-10-18
ARCHITECT AUSAB LN 1L82 (P050051/S022)Abbott Laboratories, Inc.2013-10-18
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR (P090028/S007)Ortho-Clinical Diagnostics, Inc.2013-10-17
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR (P100001/S006)Ortho-Clinical Diagnostics2013-10-17
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S028)Ortho-Clinical Diagnostics, Inc.2013-10-17
HBV ASSAY (P080026/S006)Abbott Molecular, Inc.2013-10-15
COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S011)Roche Molecular Systems, Inc.2013-10-09
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S036)Roche Molecular Systems, Inc.2013-10-09
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S037)Roche Molecular Systems, Inc.2013-10-09
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S046)Roche Molecular Systems, Inc.2013-10-09
AMPHLIPRE/COBAS TAQMAN HBV TEST (P050028/S036)Roche Molecular Systems, Inc.2013-10-09
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S045)Roche Molecular Systems, Inc.2013-10-09
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S037)Roche Molecular Systems, Inc.2013-10-09
AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S010)Roche Molecular Systems, Inc.2013-10-09
ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S014)OraSure Technologies, Inc.2013-10-03
ADVIA CENTAUR ANTI-HBS2 ASSAY (P100039/S001)Siemens Healthcare Diagnostics, Inc.2013-10-03
ARCHITECT CORE (P080023/S022)Abbott Laboratories2013-09-27
ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S013)OraSure Technologies, Inc.2013-09-26
ADVIA CENTAUR ANTI-HBS2 MASTER CURVE MATERIALS (P100039/S002)Siemens Healthcare Diagnostics, Inc.2013-09-26
ABBOTT REAL TIME HCV (P100017/S005)Abbott Molecular, Inc.2013-09-25
COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S009)Roche Molecular Systems, Inc.2013-09-12
COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM, COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 TEST (P050028/S035)Roche Molecular Systems, Inc.2013-09-12
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, COBAS TAQMAN HCV TEST, V 2.0 FOR USE WITH THE HIGH PURE SYSTEM (P060030/S035)Roche Molecular Systems, Inc.2013-09-12
COBAS HPV TEST (P100020/S011)Roche Molecular Systems, Inc.2013-09-12
COBAS AMPLICOR HCV TEST, COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S044)Roche Molecular Systems, Inc.2013-09-12
ABBOTT REAL TIME HBV (P080026/S008)Abbott Molecular, Inc.2013-09-10
COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PRESSURE SYSTEM, COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S034)Roche Molecular Systems, Inc.2013-09-06
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST VERSION 2.0, COBAS TAQMAN HCV TEST VERSION 2.0 FOR USE WITH THE HIGH PURE SYSTEM (P060030/S034)Roche Molecular Systems, Inc.2013-09-06
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S021)Ortho-Clinical Diagnostics2013-09-06
COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S008)Roche Molecular Systems, Inc.2013-09-06
COBAS HPV TEST (P100020/S010)Roche Molecular Systems, Inc.2013-09-06
T-SPOT .TB TEST (P070006/S011)Oxford Immunotec, Ltd.2013-09-03
ARCHITECT ANTI-HCV LN 1L79 (P050042/S025)Abbott Laboratories, Inc.2013-08-30
CERVISTA HPV HR ASSAY (P080014/S017)Hologic, Inc.2013-08-22
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST,V2.0,; HIGH PURE/COBAS TAQMAN HCV V20.3 TEST (P060030/S033)Roche Molecular Systems, Inc.2013-08-21
COBAS AMPLIPREP/CONAS TAQMAN CMV TEST (P110037/S007)Roche Molecular Systems, Inc.2013-08-21
COBAS HPV TEST (P100020/S009)Roche Molecular Systems, Inc.2013-08-21
ABBOTT REALTIME HCV GENOTYPE II (P120012/S003)Abbott Molecular2013-08-20
ABBOTT REALTIME HBV (P080026/S009)Abbott Molecular, Inc.2013-08-20
ABBOTT REALTIME HCV (P100017/S007)Abbott Molecular, Inc.2013-08-20
ABBOTT REALTIME HCV GENOTYPE II (P120012/S002)Abbott Molecular2013-08-13
ELECSYS ANTI-HBC IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC (P100031/S009)Roche Diagnostics Corp.2013-08-12
ABBOTT ARCHITECT HBSAG QUALITATIVE CONFIRMATORY REAGENT (P110029/S012)Abbott Laboratories2013-08-08
ABBOTT REAL TIME HCV GENOTYPE 11 (P120012/S001)Abbott Molecular2013-08-01
ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S012)OraSure Technologies, Inc.2013-08-01
ARCHITECT AUSAB (P050051/S021)Abbott Laboratories, Inc.2013-07-18
ARCHITECT HBSAG/HBSAG CONFIRMATORY (P060007/S027)Abbott Laboratories2013-07-18
APTIMA HPV ASSAY (P100042/S001)Gen-Probe Incorporated2013-07-15
ETI-CORE-IGMK PLUS (P990044/S015)DiaSorin, Inc.2013-06-25
ETI-AB-EBK PLUS ASSAY (P990041/S017)DiaSorin, Inc.2013-06-25
ETI-MAK-2 PLUS ASSAY (P990038/S018)DiaSorin, Inc.2013-06-25
ROCHE COBAS HPV TEST (P100020/S004)Roche Molecular Systems, Inc.2013-06-25
ETI-AB-AUK PLUS ASSAY (P990042/S014)DiaSorin, Inc.2013-06-25
ETI-EBK PLUS ASSAY (P990043/S018)DiaSorin, Inc.2013-06-25
ETI-AB-COREK PLUS (P990045/S015)DiaSorin, Inc.2013-06-25
COBAS TAQMAN HBV FOR USE WITH THE HIGH PURE SYSTEM (P050028/S033)Roche Molecular Systems, Inc.2013-06-24
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, V2.0 (P000012/S043)Roche Molecular Systems, Inc.2013-06-24
ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG) (P120012)Abbott Molecular2013-06-20
T-SPOT .TB TEST (P070006/S009)Oxford Immunotec, Ltd.2013-06-12
COBAS AMPLICOR HCV TEST V2.0,COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S042)Roche Molecular Systems, Inc.2013-06-07
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST,V2.0 (P050028/S032)Roche Molecular Systems, Inc.2013-06-06
COBAS AMPLIPREP/COBRA TAQMAN CMV TEST (P110037/S006)Roche Molecular Systems, Inc.2013-06-06
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, V2.0 (P000012/S041)Roche Molecular Systems, Inc.2013-06-06
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST V2.0 (P060030/S032)Roche Molecular Systems, Inc.2013-06-06
BREATH TEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR (P100025/S004)Meridian Bioscience, Inc.2013-05-29
ABBOTT REALTIME HBV (P080026/S007)Abbott Molecular, Inc.2013-05-28
ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S011)OraSure Technologies, Inc.2013-05-28
ABBOTT REALTIME HCV (P100017/S006)Abbott Molecular, Inc.2013-05-28
BREATH TEK UBT FOR H PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION(PUHR-CA) (P100025/S002)Meridian Bioscience, Inc.2013-05-23
ARCHITECT ANTI-HCV (P050042/S024)Abbott Laboratories, Inc.2013-05-22
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