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Microbiology

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

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RecordFirmDate
LIAISON® XL Murex Anti-HBc and LIAISON® XL Murex Control Anti-HBc (P180038/S007)DiaSorin, Inc.2021-12-21
LIAISON® XL Murex Anti-HBs, LIAISON® XL Murex Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers (P180039/S006)DiaSorin, Inc.2021-12-21
LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® Control QuantiFERON® - TB Gold Plus (P180047/S012)DiaSorin, Inc.2021-12-21
ETI-CORE-IGMK PLUS assay (P990044/S029)DiaSorin, Inc.2021-12-21
LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (P180045/S006)DiaSorin, Inc.2021-12-17
LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S006)DiaSorin, Inc.2021-12-17
LIAISON® XL MUREX anti-HBc and LIAISON® XL MUREX Control anti-HBc (P180038/S009)DiaSorin, Inc.2021-12-17
LIAISON® QuantiFERON-TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S013)DiaSorin, Inc.2021-12-17
LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers (P180039/S008)DiaSorin, Inc.2021-12-17
LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (P180048/S006)DiaSorin, Inc.2021-12-17
Elecsys HBsAg II (P160019/S013)Roche Diagnostics, Inc.2021-12-16
Elecsys Anti-HBs (P010054/S041)Roche Diagnostics Corp.2021-12-16
Elecsys Anti-HBs II (P190034/S001)Roche Diagnostics2021-12-16
ARCHITECT HBsAg Qualitative/Confirmatory / Alinity i HBsAg Qualitative II/Confirmatory (P110029/S036)Abbott Laboratories2021-12-15
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S036)Abbott Laboratories2021-12-15
ARCHITECT Anti-HCV / Alinity i Anti-HCV (P050042/S047)Abbott Laboratories, Inc.2021-12-15
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S034)Abbott Laboratories2021-12-15
ARCHITECT AUSAB / Alinity i Anti-HBs (P050051/S045)Abbott Laboratories, Inc.2021-12-15
QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus (P010033/S047)Qiagen2021-12-13
Elecsys HBsAg Confirmatory Test (P160019/S012)Roche Diagnostics, Inc.2021-12-09
ARCHITECT AUSAB (LN 1L82) (P050051/S044)Abbott Laboratories, Inc.2021-12-06
ARCHITECT CORE (LN 6L22) (P080023/S035)Abbott Laboratories2021-12-06
ARCHITECT CORE-M (LN 6L23) (P060035/S033)Abbott Laboratories2021-12-06
ARCHITECT HBsAg Qualitative (LN 4P53), ARCHITECT HBsAg Qualitative Confirmatory (LN 4P54) (P110029/S035)Abbott Laboratories2021-12-06
ARCHITECT Anti-HCV (LN 1L79) (P050042/S046)Abbott Laboratories, Inc.2021-12-06
LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus (P180047/S009)DiaSorin, Inc.2021-11-16
Elecsys Anti-HBe, PreciControl Anti-HBe (P190005/S001)Roche Diagnostics2021-11-01
LIAISON QuantiFERON-TB Gold Plus and LIAISON Control QuantiFERON-TB Gold Plus (P180047/S008)DiaSorin, Inc.2021-09-17
Abbott ARCHITECT AUSAB Reagent (100 Test), Abbott ARCHITECT AUSAB Reagent (500 Test), Abbott ARCHITECT AUSAB Reagent, Al (P050051/S042)Abbott Laboratories, Inc.2021-09-09
BD Onclarity HPV Assay/BD COR System (P160037/S005)Becton, Dickinson and Company2021-08-24
COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 (P060030/S086)Roche Molecular Systems, Inc.2021-08-11
COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S056)Roche Molecular Systems, Inc.2021-08-11
COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S085)Roche Molecular Systems, Inc.2021-08-11
LIAISON XL MUREX HBsAg Qual, LIAISON XL MUREX Control HBsAg Qual (P190017/S002)DiaSorin, Inc.2021-08-10
LIAISON XL MUREX Anti-HBc, LIAISON XL MUREX Control Anti-HBc (P180038/S005)DiaSorin, Inc.2021-08-10
LIAISON XL MUREX Anti-HBe, LIAISON XL MUREX Control Anti-HBe (P180049/S002)DiaSorin, Inc.2021-08-10
LIAISON QuantiFERON-TB Gold Plus, LIAISON XL Control QuantiFERON-TB Gold Plus (P180047/S010)DiaSorin, Inc.2021-08-10
LIAISON XL MUREX HCV Ab, LIAISON XL MUREX Control HCV Ab (P190011/S004)DiaSorin, Inc.2021-08-10
LIAISON XL MUREX HBeAg, LIAISON XL MUREX Control HBeAg (P180048/S002)DiaSorin, Inc.2021-08-10
LIAISON XL MUREX Anti-HBs, LIAISON XL MUREX Control Anti-HBs and LIAISON XL MUREX Anti-HBs Verifiers (P180039/S004)DiaSorin, Inc.2021-08-10
LIAISON XL MUREX HBc IgM, LIAISON XL MUREX Control HBc IgM (P180045/S002)DiaSorin, Inc.2021-08-10
T-SPOT.TB Test (P070006/S017)Oxford Immunotec, Ltd.2021-07-26
ADVIA Centaur Anti-HBe2 (aHBe2) assay (P200017)Siemens Healthcare Diagnostics, Inc.2021-07-14
IMMULITE 2000 HBs Ag Confirmatory (P010050/S019)Siemens Healthcare Diagnostics Products, Ltd.2021-06-09
cobas HPV (P190028/S005)Roche Molecular Systems, Inc.2021-06-02
cobas CMV (P160041/S033)Roche Molecular Systems, Inc.2021-06-02
cobas HCV (P150015/S043)Roche Molecular Systems, Inc.2021-06-02
cobas HBV (P150014/S041)Roche Molecular Systems, Inc.2021-06-02
Alinity m HCV (P190025/S006)Abbott Molecular, Inc.2021-06-01
Alinity m HBV (P200013/S005)Abbott Molecular, Inc.2021-06-01
ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit (P060035/S031)Abbott Laboratories2021-05-14
Atellica IM Hepatitis B surface Antigen II (HBsll), Atellica IM Hepatitis B surface Antigen 11 Confirmatory (HBsll Conf) (P110041/S012)Siemens Corp.2021-04-27
Atellica IM Anti-Hepatitis B core Total (HBcT) Assay (P040004/S020)Siemens Healthcare Diagnostics2021-04-27
Atellica IM Hepatitis B e Antigen (HBeAg) Assay (P090024/S010)Siemens Healthcare Diagnostics2021-04-27
Atellica IM Hepatitis B core IgM (aHBcM) Assay (P030040/S020)Siemens Healthcare Diagnostics2021-04-27
Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay (P100039/S013)Siemens Healthcare Diagnostics, Inc.2021-04-27
Atellica IM Hepatitis C (aHCV) Assay (P030056/S020)Siemens Healthcare Diagnostics2021-04-27
Alinity m HCV (P190025/S004)Abbott Molecular, Inc.2021-04-26
Alinity m HBV (P200013/S002)Abbott Molecular, Inc.2021-04-26
ARCHITECT Anti-HCV Reagent Kit, Alinity i Anti-HCV Reagent Kit (P050042/S045)Abbott Laboratories, Inc.2021-04-22
ARCHITECT AUSAB Reagent, ARCHITECT AUSAB Reagent Kit, Alinity i Anti-HBs Reagent Kit (P050051/S041)Abbott Laboratories, Inc.2021-04-22
ARCHITECT CORE Reagent Kit, Alinity i Anti-HBc Reagent Kit (P080023/S034)Abbott Laboratories2021-04-22
ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit (P060035/S032)Abbott Laboratories2021-04-22
ARCHITECT HBsAg Qualitative Reagent, ARCHITECT HBsAg Qualitative Confirmatory Reagent, Alinity i HBsAg Qualitative II Re (P110029/S034)Abbott Laboratories2021-04-22
OraQuick HCV Rapid Antibody Test (P080027/S039)OraSure Technologies, Inc.2021-04-20
ADVIA Centaur aHBs2 Assay (P100039/S012)Siemens Healthcare Diagnostics, Inc.2021-04-13
T-SPOT.TB TEST (P070006/S016)Oxford Immunotec, Ltd.2021-03-22
ADVIA Centaur Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM He (P030040/S019)Siemens Healthcare Diagnostics2021-03-11
IMMULITE 2000/2000 XPi Anti-HBc IgM (P010053/S013)Siemens Healthcare Diagnostics Products, Ltd.2021-03-11
ADVIA Centaur HBc Total ReadyPack Reagents, ADVIA Centaur HBc Total Quality Control Materials, Atellica IM Anti-Hepatiti (P040004/S019)Siemens Healthcare Diagnostics2021-03-11
ADVIA Centaur HBsAg ReadyPack Reagents/ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, ADVIA Centaur HBsAg Quality (P030049/S016)Siemens Healthcare Diagnostics2021-03-11
IMMULITE 2000/2000 XPi Anti-HBc (P010051/S014)Siemens Healthcare Diagnostics Products, Ltd.2021-03-11
ADVIA Centaur HCV ReadyPack Reagents, Atellica IM Hepatitis C (aHCV), Atellica IM Hepatitis C Quality Control(aHCV QC) (P030056/S019)Siemens Healthcare Diagnostics2021-03-11
ADVIA Centaur anti-HBs2 (aHBs2), ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control Material, Atellica IM Anti-Hepatitis B (P100039/S011)Siemens Healthcare Diagnostics, Inc.2021-03-11
ADVIA Centaur HBsAg II(HBsII), ADVIA Centaur HBsAg Confirmatory, ADVIA Centaur HBsAg Quality Control Material, Atellica (P110041/S011)Siemens Corp.2021-03-11
COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 (P060030/S085)Roche Molecular Systems, Inc.2021-03-09
COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S055)Roche Molecular Systems, Inc.2021-03-09
COBAS AmpliPrep/COBAS TaqMan HBV Test, V2.0 (P050028/S084)Roche Molecular Systems, Inc.2021-03-09
Alinity m HBV (P200013/S004)Abbott Molecular, Inc.2021-03-08
Abbott RealTime CMV (P160044/S003)Abbott Molecular2021-03-05
Abbott RealTime HCV Genotype II (P120012/S019)Abbott Molecular2021-03-05
Abbott RealTime HBV (P080026/S024)Abbott Molecular, Inc.2021-03-05
Abbott RealTime HCV (P100017/S024)Abbott Molecular, Inc.2021-03-05
Alinity m HCV (P190025/S005)Abbott Molecular, Inc.2021-03-05
Alinity m HBV (P200013/S003)Abbott Molecular, Inc.2021-03-05
OraQuick HCV Rapid Antibody Test (P080027/S038)OraSure Technologies, Inc.2021-02-25
Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck (P190034)Roche Diagnostics2021-02-23
Elecsys Anti-HBe, PreciControl Anti-HBe (P190005)Roche Diagnostics2021-02-03
Alinity m HCV (P190025/S003)Abbott Molecular, Inc.2021-01-19
Alinity m HBV (P200013/S001)Abbott Molecular, Inc.2021-01-19
cobas CMV (P160041/S032)Roche Molecular Systems, Inc.2020-12-10
cobas HCV (P150015/S042)Roche Molecular Systems, Inc.2020-12-10
cobas HPV (P190028/S004)Roche Molecular Systems, Inc.2020-12-10
cobas HBV (P150014/S040)Roche Molecular Systems, Inc.2020-12-10
Abbott RealTime HCV Assay (P100017/S023)Abbott Molecular, Inc.2020-12-08
Abbott RealTime HBV Assay (P080026/S023)Abbott Molecular, Inc.2020-12-04
LIAISON QuantiFERON-TB Gold Plus (P180047/S006)DiaSorin, Inc.2020-11-25
ARCHITECT AUSAB and Alinity i Anti-HBs (P050051/S040)Abbott Laboratories, Inc.2020-11-05
cobas HBV (P150014/S037)Roche Molecular Systems, Inc.2020-11-02
cobas HCV (P150015/S039)Roche Molecular Systems, Inc.2020-11-02
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