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Microbiology

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

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RecordFirmDate
LIAISON XL MUREX HBc IgM; LIAISON XL MUREX Control HBc IgM (P180045/S018)DiaSorin, Inc.2025-02-25
LIAISON QuantiFERON-TB Gold Plus; LIAISON Control QuantiFERON-TB Gold Plus (P180047/S033)DiaSorin, Inc.2025-02-25
-LIAISON Biotrin Parvovirus B19 IgG Plus; LIAISON Biotrin Control Parvovirus B19 IgG Plus (P220034/S005)DiaSorin, Inc.2025-02-25
LIAISON XL MUREX Anti-HBe; LIAISON XL MUREX Control Anti-HBe (P180049/S019)DiaSorin, Inc.2025-02-25
LIAISON XL MUREX Anti-HBs; LIAISON XL MUREX Control Anti-HBs; LIAISON XL Murex Anti-HBs Verifiers (P180039/S021)DiaSorin, Inc.2025-02-25
T SPOT-TB (P070006/S026)Oxford Immunotec, Ltd.2025-02-20
PyloPlus UBT System (P170022/S005)Arj Medical, Inc.2025-02-12
Atellica IM Hepatitis B e Antigen (HBeAg) (P090024/S012)Siemens Healthcare Diagnostics2025-01-13
Parvovirus B 19 IgM Enzyme Immunoassay (P970055/S024)Diasorin2025-01-06
LIAISON XL MUREX Anti-HBe and LIAISON XL MUREX Control Anti-HBe (P180049/S017)DiaSorin, Inc.2025-01-06
LIAISON XL MUREX HBeAg and LIAISON XL MUREX Control HBeAg (P180048/S017)DiaSorin, Inc.2025-01-06
Parvovirus B 19 IgG Enzyme Immunoassay (P970054/S022)Diasorin2025-01-06
LIAISON QuantiFERON - TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus (P180047/S031)DiaSorin, Inc.2025-01-06
LIAISON XL MUREX Anti-HBs, LIAISON XL MUREX Control Anti-HBs and LIAISON XL Murex Anti-HBs Verifiers (P180039/S019)DiaSorin, Inc.2025-01-06
LIAISON Biotrin Parvovirus B19 lgG Plus and LIAISON Biotrin Control Parvovirus B19 IgG Plus (P220034/S003)DiaSorin, Inc.2025-01-06
LIAISON XL MUREX HBc IgM and LIAISON XL MUREX Control HBc IgM (P180045/S016)DiaSorin, Inc.2025-01-06
LIAISON XL Murex Anti-HBc and LIAISON XL MUREX Control anti-HBc (P180038/S020)DiaSorin, Inc.2025-01-06
LIAISON XL MUREX HBsAg Qual and LIAISON XL MUREX Control HBsAg Qual (P190017/S022)DiaSorin, Inc.2025-01-06
Alinity m HBV (P200013/S023)Abbott Molecular, Inc.2024-12-23
LIAISON XL MUREX HBsAg Qual and LIAISON XL MUREX Control HBsAg Qual and LIAISON XL MUREX HBsAg Confirmatory (P190017/S021)DiaSorin, Inc.2024-12-19
Atellica IM Hepatitis B core IgM (aHBcM) (P030040/S023)Siemens Healthcare Diagnostics2024-12-17
LIAISON QuantiFERON - TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus (P180047/S030)DiaSorin, Inc.2024-12-13
Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110031/S025)Roche Diagnostics Corp.2024-11-22
Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110022/S031)Roche Diagnostics Corp.2024-11-22
BD Onclarity™ HPV Assay (P160037/S020)Becton, Dickinson and Company2024-11-05
Aptima HPV-GT Assay (P120007/S032)Gen-Probe Incorporated2024-10-23
Aptima HPV Assay (P100042/S037)Gen-Probe Incorporated2024-10-23
Aptima CMV Quant Assay (P210029/S002)Hologic, Inc.2024-10-23
Aptima HBV Quant Assay (P170025/S022)Hologic, Inc.2024-10-23
LIAISON QuantiFERON-TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus (P180047/S028)DiaSorin, Inc.2024-10-11
COBAS CMV (P160041/S045)Roche Molecular Systems, Inc.2024-10-10
COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S064)Roche Molecular Systems, Inc.2024-10-04
cobas HBV (P150014/S052)Roche Molecular Systems, Inc.2024-10-04
cobas CMV (P160041/S043)Roche Molecular Systems, Inc.2024-10-04
COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S094)Roche Molecular Systems, Inc.2024-10-04
cobas HPV (P190028/S017)Roche Molecular Systems, Inc.2024-10-04
Elecsys HBsAg II (P160019/S018)Roche Diagnostics, Inc.2024-10-03
Elecsys HBeAg (P130015/S021)Roche Diagnostics Operations, Inc.2024-10-03
Elecsys Anti-HBc II / Elecsys Anti-HBc IgM (P110022/S033)Roche Diagnostics Corp.2024-10-03
Elecsys Anti-HBe (P190005/S006)Roche Diagnostics2024-10-03
Elecsys Anti-HBc IgM (P110031/S026)Roche Diagnostics Corp.2024-10-03
Elecsys Anti-HBs / Elecsys HBs II (P190034/S009)Roche Diagnostics2024-10-03
Elecsys Anti-HBc II / Elecsys Anti-HBc IgM (P100031/S032)Roche Diagnostics Corp.2024-10-03
Elecsys Anti-HBs / Elecsys HBs II (P010054/S047)Roche Diagnostics Corp.2024-10-03
cobas CMV (P160041/S044)Roche Molecular Systems, Inc.2024-10-02
cobas HBV (P150014/S053)Roche Molecular Systems, Inc.2024-10-02
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30
ARCHITECT HBsAg Qualitative/Confirmatory, Alinity i HBsAg Qualitative II/ Confirmatory (P110029/S051)Abbott Laboratories2024-09-30
cobas® CMV (P160041/S046)Roche Molecular Systems, Inc.2024-09-27
cobas® HPV (P190028/S018)Roche Molecular Systems, Inc.2024-09-27
cobas® HBV (P150014/S055)Roche Molecular Systems, Inc.2024-09-27
Alinity m HBV Assay (P200013/S021)Abbott Molecular, Inc.2024-09-13
Alinity m HR HPV Assay (P230003/S004)Abbott Molecular, Inc.2024-09-13
Alinity m CMV Assay (P210022/S012)Abbott Molecular, Inc.2024-09-13
cobas HPV (P190028/S016)Roche Molecular Systems, Inc.2024-09-11
COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S063)Roche Molecular Systems, Inc.2024-09-11
cobas CMV (P160041/S042)Roche Molecular Systems, Inc.2024-09-11
cobas HBV (P150014/S051)Roche Molecular Systems, Inc.2024-09-11
COBAS AmpliPrep/ COBAS TaqMan HBV Test, v 2.0 (P050028/S093)Roche Molecular Systems, Inc.2024-09-11
Alinity m CMV Assay (P210022/S013)Abbott Molecular, Inc.2024-09-05
Alinity m HBV Assay (P200013/S022)Abbott Molecular, Inc.2024-09-05
Alinity m HR HPV Assay (P230003/S005)Abbott Molecular, Inc.2024-09-05
LIAISON® QuantiFERON®-TB Gold Plus, LIAISON® Control QuantiFERON®-TB Gold Plus (P180047/S027)DiaSorin, Inc.2024-09-05
Elecsys Anti-HBc II (P100031/S031)Roche Diagnostics Corp.2024-08-29
Elecsys Anti-HBs (P010054/S046)Roche Diagnostics Corp.2024-08-29
Elecsys Anti-HBc IgM (P110022/S032)Roche Diagnostics Corp.2024-08-29
Elecsys HBeAg (P130015/S020)Roche Diagnostics Operations, Inc.2024-08-29
Elecsys Anti-HBs II (P190034/S008)Roche Diagnostics2024-08-29
Elecsys HBsAg II (P160019/S017)Roche Diagnostics, Inc.2024-08-29
Elecsys Anti-HBe (P190005/S005)Roche Diagnostics2024-08-29
cobas HPV Test (P100020/S061)Roche Molecular Systems, Inc.2024-08-14
Aptima HPV-GT Assay (P120007/S031)Gen-Probe Incorporated2024-07-26
Aptima HPV Assay (P100042/S036)Gen-Probe Incorporated2024-07-26
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007)Roche Diagnostics2024-07-23
Atellica IM HBc Total 2 (HBcT2) (P210019/S003)Siemens Healthcare Diagnostics, Inc.2024-07-22
LIAISON® XL MUREX HBsAg Qual, LIAISON® XL MUREX Control HBsAg Qual (P190017/S020)DiaSorin, Inc.2024-07-12
LIAISON® QuantiFERON® - TB Gold Plus, LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S026)DiaSorin, Inc.2024-07-12
LIAISON® XL Murex Anti-HBc, LIAISON® XL MUREX Control anti-HBc (P180038/S019)DiaSorin, Inc.2024-07-12
LIAISON® XL Murex Anti-HBs, LIAISON® XL MUREX Control Anti-HBs, LIAISON® XL Murex Anti-HBs Verifier (P180039/S018)DiaSorin, Inc.2024-07-12
Parvovirus B19 IgM Enzyme Immunoassay (P970055/S023)Diasorin2024-07-12
Parvovirus B19 IgG Enzyme Immunoassay (P970054/S021)Diasorin2024-07-12
LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM (P180045/S015)DiaSorin, Inc.2024-07-12
LIAISON® Biotrin Parvovirus B 19 IgG Plus, LIAISON® Biotrin Control Parvovirus B 19 IgG Plus (P220034/S002)DiaSorin, Inc.2024-07-12
LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg (P180048/S016)DiaSorin, Inc.2024-07-12
LIAISON® XL MUREX Anti-HBe, LIAISON® XL MUREX Control Anti-HBe (P180049/S016)DiaSorin, Inc.2024-07-12
Alinity m CMV Assay (P210022/S011)Abbott Molecular, Inc.2024-07-10
Alinity m HR HPV Assay (P230003/S003)Abbott Molecular, Inc.2024-07-10
Alinity m HBV Assay (P200013/S020)Abbott Molecular, Inc.2024-07-10
cobas HPV (P190028/S015)Roche Molecular Systems, Inc.2024-07-01
Roche cobas HBV (P150014/S050)Roche Molecular Systems, Inc.2024-07-01
cobas CMV (P160041/S041)Roche Molecular Systems, Inc.2024-07-01
T SPOT-TB TEST (P070006/S025)Oxford Immunotec, Ltd.2024-06-25
Aptima HBV Quant Assay (P170025/S019)Hologic, Inc.2024-06-17
cobas® HPV Test (P100020/S060)Roche Molecular Systems, Inc.2024-06-14
LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus (P220034/S001)DiaSorin, Inc.2024-06-04
LIAISON XL MUREX HBc IgM and LIAISON XL MUREX Control HBc IgM (P180045/S014)DiaSorin, Inc.2024-06-04
LIAISON QuantiFERON - TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus (P180047/S025)DiaSorin, Inc.2024-06-04
LIAISON XL MUREX HBsAg Qual and LIAISON XL MUREX Control HBsAg Qual (P190017/S019)DiaSorin, Inc.2024-06-04
LIAISON XL Murex Anti-HBs, LIAISON XL MUREX Control Anti-HBs and LIAISON XL Murex Anti-HBs Verifier (P180039/S016)DiaSorin, Inc.2024-06-04
LIAISON XL MUREX anti-HBe, LIAISON XL MUREX Control anti-HBe (P180049/S015)DiaSorin, Inc.2024-06-04
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