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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/S018)DiaSorin, Inc.2024-06-04
LIAISON XL MUREX HBeAg and LIAISON XL MUREX Control HBeAg (P180048/S015)DiaSorin, Inc.2024-06-04
T-SPOT.TB Test (P070006/S023)Oxford Immunotec, Ltd.2024-06-04
ARCHITECT AUSAB/Alinity i Anti-HBs (P050051/S060)Abbott Laboratories, Inc.2024-05-23
ARCHITECT HBsAg Qualitative Confirmatory/ Alinity i HBsAg Qualitative II Confirmatory (P110029/S050)Abbott Laboratories2024-05-23
BD Onclarity HPV Assay (P160037/S017)Becton, Dickinson and Company2024-05-14
cobas HPV Test (P100020/S055)Roche Molecular Systems, Inc.2024-05-14
cobas HPV (P190028/S009)Roche Molecular Systems, Inc.2024-05-14
Aptima HBV Quant Assay (P170025/S021)Hologic, Inc.2024-05-08
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005)Roche Diagnostics2024-05-01
LIAISON Murex Anti-HBc and LIAISON Murex Control Anti-HBc (P180038/S017)DiaSorin, Inc.2024-04-22
BD Onclarity™ HPV Assay (P160037/S019)Becton, Dickinson and Company2024-04-18
LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus (P220034)DiaSorin, Inc.2024-03-29
ARCHITECT CORE/ Alinity i Anti-HBc (P080023/S045)Abbott Laboratories2024-03-22
ARCHITECT AUSAB / Alinity i Anti-HBs (P050051/S059)Abbott Laboratories, Inc.2024-03-22
ARCHITECT HBsAg Next Qualitative I Qualitative Confirmatory/ Alinity i HBsAg Next Qualitative I Alinity i HBsAg Next Con (P210003/S011)Abbott Laboratories2024-03-22
cobas® HPV (P100020/S059)Roche Molecular Systems, Inc.2024-02-23
COBAS® AmpliPrep®, COBAS® TaqMan® HBV Test, v2.0 (P050028/S092)Roche Molecular Systems, Inc.2024-02-23
COBAS® AmpliPrep®, COBAS® TaqMan® CMV Test (P110037/S062)Roche Molecular Systems, Inc.2024-02-23
QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus Test (P010033/S050)Qiagen2024-02-09
Elecsys Anti-HBc IgM (P110022/S030)Roche Diagnostics Corp.2024-02-08
Elecsys HBeAg (P130015/S019)Roche Diagnostics Operations, Inc.2024-02-08
Elecsys Anti-HBe (P190005/S004)Roche Diagnostics2024-02-08
Elecsys Anti-HBs (P010054/S045)Roche Diagnostics Corp.2024-02-08
Elecsys Anti-HBc II (P100031/S030)Roche Diagnostics Corp.2024-02-08
Elecsys Anti-HBs II (P190034/S006)Roche Diagnostics2024-02-08
Elecsys HBsAg II (P160019/S016)Roche Diagnostics, Inc.2024-02-08
Alinity m HR HPV (P230003/S001)Abbott Molecular, Inc.2024-02-05
Alinity m CMV (P210022/S009)Abbott Molecular, Inc.2024-02-05
Alinity m HBV (P200013/S018)Abbott Molecular, Inc.2024-02-05
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S003)Roche Diagnostics2024-01-31
Elecsys Anti-HBs, PreciControl Anti-HBs (P010054/S043)Roche Diagnostics Corp.2024-01-31
Alinity m HR HPV Assay (P230003/S002)Abbott Molecular, Inc.2024-01-20
Alinity m HBV Assay (P200013/S019)Abbott Molecular, Inc.2024-01-20
Alinity m CMV Assay (P210022/S010)Abbott Molecular, Inc.2024-01-20
ARCHITECT AUSAB (P050051/S050)Abbott Laboratories, Inc.2024-01-19
cobas® HBV (P150014/S049)Roche Molecular Systems, Inc.2024-01-18
Alinity m CMV (P210022/S008)Abbott Molecular, Inc.2024-01-16
T-SPOT®.TB Test (P070006/S022)Oxford Immunotec, Ltd.2024-01-11
PyloPlus® UBT System (P170022/S003)Arj Medical, Inc.2024-01-11
QuantiFERON®-TB Gold Plus Test (P010033/S049)Qiagen2023-12-15
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S042)Abbott Laboratories2023-12-14
ARCHITECT HBsAg Next Qualitative / Alinity i HBsAg Next Qualitative, ARCHITECT HBsAg NEXT Confirmatory / Alinity i HBsAg (P210003/S010)Abbott Laboratories2023-12-14
ARCHITECT HBsAg Qualitative / Alinity i HBsAg Qualitative II (P110029/S049)Abbott Laboratories2023-12-14
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S044)Abbott Laboratories2023-12-14
COBAS® AmpliPrep® / COBAS® TaqMan® HBV Test, v2.0 (P050028/S091)Roche Molecular Systems, Inc.2023-12-14
cobas® HPV (P190028/S014)Roche Molecular Systems, Inc.2023-12-14
cobas® HPV (P100020/S058)Roche Molecular Systems, Inc.2023-12-14
cobas® CMV (P160041/S040)Roche Molecular Systems, Inc.2023-12-14
cobas® HBV (P150014/S047)Roche Molecular Systems, Inc.2023-12-14
COBAS® AmpliPrep® / COBAS® TaqMan® HBV Test, v2.0 (P050028/S089)Roche Molecular Systems, Inc.2023-12-14
COBAS® AmpliPrep® / COBAS® TaqMan® CMV Test (P110037/S060)Roche Molecular Systems, Inc.2023-12-14
cobas HPV (P190028/S013)Roche Molecular Systems, Inc.2023-12-14
ARCHITECT AUSAB / Alinity i Anti-HBs (P050051/S058)Abbott Laboratories, Inc.2023-12-14
COBAS® AmpliPrep® / COBAS® TaqMan® CMV Test (P110037/S061)Roche Molecular Systems, Inc.2023-12-14
cobas® HBV (P150014/S048)Roche Molecular Systems, Inc.2023-12-14
cobas® CMV (P160041/S039)Roche Molecular Systems, Inc.2023-12-14
T-SPOT. TB TEST (P070006/S020)Oxford Immunotec, Ltd.2023-12-12
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S009)Abbott Laboratories2023-12-07
ARCHITECT HBsAg Qualitative/Confirmatory, Alinity i HBsAg Qualitative II/Confirmatory (P110029/S048)Abbott Laboratories2023-12-07
ARCHITECT AUSAB, Alinity i Anti-HBs (P050051/S057)Abbott Laboratories, Inc.2023-12-07
T-SPOT®.TB Test (P070006/S021)Oxford Immunotec, Ltd.2023-12-04
Aptima HBV Quant Assay (P170025/S020)Hologic, Inc.2023-11-24
BD Onclarity HPV Assay (P160037/S018)Becton, Dickinson and Company2023-11-20
BD Onclarity HPV (P160037/S016)Becton, Dickinson and Company2023-11-15
LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S014)DiaSorin, Inc.2023-11-08
LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control Anti-HBc (P180038/S016)DiaSorin, Inc.2023-11-08
LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test (P190017/S017)DiaSorin, Inc.2023-11-08
LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers (P180039/S015)DiaSorin, Inc.2023-11-08
LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (P180045/S013)DiaSorin, Inc.2023-11-08
LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (P180048/S014)DiaSorin, Inc.2023-11-08
LIAISON® QuantiFERON-TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S024)DiaSorin, Inc.2023-11-08
Alinity i Anti-HBc IgM Reagent Kit (2xl00 Tests) (P060035/S041)Abbott Laboratories2023-11-06
Alinity i Anti-HBs Reagent Kit (2x 100 Tests), Alinity i Anti-HBs Reagent Kit (2x600 Tests), Alinity i Anti-HBs Reagent (P050051/S056)Abbott Laboratories, Inc.2023-11-06
Alinity i HBsAg Qualitative II Reagent Kit (2x l 00 Tests), Alinity i HBsAg Qualitative II Reagent Kit (2x600 Tests), Al (P110029/S047)Abbott Laboratories2023-11-06
Alinity i Anti-HBc Reagent Kit (2x 100 Tests), Alinity i Anti-HBc Reagent Kit (2x600 Tests) (P080023/S043)Abbott Laboratories2023-11-06
Alinity i Anti-HBc Reagent Kit (2x100 Tests), Alinity i Anti-HBc Reagent Kit (2x600 Tests) (P080023/S042)Abbott Laboratories2023-11-03
Alinity i Anti-HBs Reagent Kit (2x100 Tests), Alinity i Anti-HBs Reagent Kit (2x600 Tests), Alinity i Anti-HBs Reagent K (P050051/S055)Abbott Laboratories, Inc.2023-11-03
Alinity i Anti-HBc IgM Reagent Kit (2x100 Tests) (P060035/S040)Abbott Laboratories2023-11-03
Alinity i HBsAg Qualitative II Reagent Kit (2x100 Tests), Alinity i HBsAg Qualitative II Reagent Kit (2x600 Tests), Alin (P110029/S046)Abbott Laboratories2023-11-03
Alinity m HR HPV (P230003)Abbott Molecular, Inc.2023-11-01
Elecsys Anti-HBe (P190005/S003)Roche Diagnostics2023-10-31
Elecsys Anti-HBs (P010054/S044)Roche Diagnostics Corp.2023-10-31
Elecsys HBsAg II, Elecsys HBsAg II Auto Confirm (P160019/S015)Roche Diagnostics, Inc.2023-10-31
Elecsys HBeAg (P130015/S018)Roche Diagnostics Operations, Inc.2023-10-31
Elecsys Anti-HBc II (P100031/S029)Roche Diagnostics Corp.2023-10-31
Elecsys Anti-HBs II (P190034/S004)Roche Diagnostics2023-10-31
Elecsys Anti-HBc IgM (P110022/S029)Roche Diagnostics Corp.2023-10-31
DML 3000 Microplate Luminometer, 5000-00031, digene® HC2 High-Risk HPV DNA Test (I plate), 5199-1220, digene® HC2 High-R (P890064/S042)Qiagen Gaithersburg, Inc.2023-10-19
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S038)Abbott Laboratories2023-10-11
ARCHITECT HBsAg Qualitative / HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative II / HBsAg Qualitative II Conf (P110029/S042)Abbott Laboratories2023-10-11
ARCHITECT AUSAB / Alinity i Anti-HBs (P050051/S051)Abbott Laboratories, Inc.2023-10-11
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S040)Abbott Laboratories2023-10-11
ARCHITECT HBsAg Next Qualitative / Next Confirmatory (P210003/S007)Abbott Laboratories2023-10-11
LIAISON® XL Murex HBsAg Qual and LIAISON® XL Murex Control HBsAg. (P190017/S016)DiaSorin, Inc.2023-10-05
cobas® HPV (P190028/S007)Roche Molecular Systems, Inc.2023-10-04
LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM (P180045/S012)DiaSorin, Inc.2023-09-28
LIAISON® QuantiFERON-TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S023)DiaSorin, Inc.2023-09-28
LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (P180048/S012)DiaSorin, Inc.2023-09-28
LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S013)DiaSorin, Inc.2023-09-28
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