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Microbiology

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

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RecordFirmDate
cobas® HPV (P190028/S022)Roche Molecular Systems, Inc.2025-12-31
cobas® HPV (P100020/S064)Roche Molecular Systems, Inc.2025-12-31
LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (P220034/S008)DiaSorin, Inc.2025-12-19
LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus (P180047/S041)DiaSorin, Inc.2025-12-19
COBAS HPV TEST (P100020/S063)Roche Molecular Systems, Inc.2025-12-15
QuantiFERON-TB Gold Plus Test (P010033/S051)Qiagen2025-11-21
Atellica IM Hepatitis B core IgM (aHBcM) (P030040/S024)Siemens Healthcare Diagnostics2025-10-17
Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) (P100039/S018)Siemens Healthcare Diagnostics, Inc.2025-10-17
Atellica IM Hepatitis B e Antigen (HBeAg) (P090024/S013)Siemens Healthcare Diagnostics2025-10-17
Atellica IM Hepatitis B surface Antigen II (HBsII) & Atellica IM Hepatitis B surface Antigen II Confirmatory (P110041/S017)Siemens Corp.2025-10-17
Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC (P230015)Beckman Coulter, Inc.2025-10-17
Atellica IM Hepatitis B surface Antigen II (HBsII) (P110041/S016)Siemens Corp.2025-10-17
Alinity m HR HPV (P230003/S009)Abbott Molecular, Inc.2025-10-17
cobas® HBV (P150014/S056)Roche Molecular Systems, Inc.2025-10-17
Atellica IM Anti-HBe2 (aHBe2) (P200017/S005)Siemens Healthcare Diagnostics, Inc.2025-10-17
Alinity m HBV (P200013/S027)Abbott Molecular, Inc.2025-10-17
Atellica IM HBc Total 2 (HBcT2) (P210019/S004)Siemens Healthcare Diagnostics, Inc.2025-10-17
LIAISON® XL Murex Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifier (P180039/S023)DiaSorin, Inc.2025-10-10
LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S021)DiaSorin, Inc.2025-10-10
LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (P220034/S007)DiaSorin, Inc.2025-10-10
LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (P180045/S020)DiaSorin, Inc.2025-10-10
LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S037)DiaSorin, Inc.2025-10-10
LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (P180048/S021)DiaSorin, Inc.2025-10-10
LIAISON® XL Murex Anti-HBc and LIAISON® XL MUREX Control anti-HBc (P180038/S025)DiaSorin, Inc.2025-10-10
LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual (P190017/S026)DiaSorin, Inc.2025-10-10
Aptima HPV 16 18/45 Genotype Assay (Box 1); Aptima HPV 16 18/45 Genotype Assay (Box 2); Aptima HPV 16 18/45 Genotype Ass (P120007/S033)Gen-Probe Incorporated2025-10-07
Aptima HBV Quant Assay Kit, 100T; Aptima HBV Quant Calibrator Kit; Aptima HBV Quant Controls Kit; Aptima HBV Quant Targe (P170025/S023)Hologic, Inc.2025-10-07
Aptima HPV Assay 250T (Panther) Box 1; Aptima HPV Assay 250T (Panther) Box 2; Aptima HPV Assay Calibrators; Aptima HPV A (P100042/S039)Gen-Probe Incorporated2025-10-07
Alinity m HR HPV (P230003/S008)Abbott Molecular, Inc.2025-09-24
Alinity m HBV (P200013/S026)Abbott Molecular, Inc.2025-09-24
cobas HPV (P190028/S021)Roche Molecular Systems, Inc.2025-09-19
cobas HBV (P150014/S058)Roche Molecular Systems, Inc.2025-09-19
IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg), IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg) Confirmatory Kit (P010050/S026)Siemens Healthcare Diagnostics Products, Ltd.2025-09-18
IMMULITE 2000 Total Antibodies to Hepatitis B Surface Antigen (Anti-HBs) (P010052/S020)Siemens Healthcare Diagnostics Products, Ltd.2025-09-18
IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg), IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg) Confirmatory Kit (P010050/S025)Siemens Healthcare Diagnostics Products, Ltd.2025-09-18
PyloPlus Urea Breath Test System (P170022/S008)Arj Medical, Inc.2025-09-16
Alinity m HR HPV (P230003/S006)Abbott Molecular, Inc.2025-09-10
LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® Control QuantiFERON-TBGold Plus (P180047/S040)DiaSorin, Inc.2025-08-28
LIAISON® Murex Anti-HBc and LIAISON® MUREX Control anti-HBc (P180038/S027)DiaSorin, Inc.2025-08-28
LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual (P190017/S028)DiaSorin, Inc.2025-08-28
BD ONCLARITY HPV ASSAY (P160037/S022)Becton, Dickinson and Company2025-08-25
LIAISON® MUREX Anti-HBc and LIAISON® MUREX Control Anti-HBc (P180038/S026)DiaSorin, Inc.2025-08-21
LIAISON® MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg Qual and LIAISON® MUREX HBsAg Confirmatory (P190017/S027)DiaSorin, Inc.2025-08-21
LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S038)DiaSorin, Inc.2025-08-21
cobas® HPV (P190028/S020)Roche Molecular Systems, Inc.2025-08-07
cobas® HBV (P150014/S057)Roche Molecular Systems, Inc.2025-08-07
T-SPOT.TB TEST (P070006/S027)Oxford Immunotec, Ltd.2025-08-04
T-SPOT.TB Test (P070006/S028)Oxford Immunotec, Ltd.2025-08-04
IMMULITE 2000 Systems Total Antibodies to Hepatitis B Core Antigen (Anti-HBc) (P010051/S023)Siemens Healthcare Diagnostics Products, Ltd.2025-08-04
BD Onclarity HPV Assay (P160037/S023)Becton, Dickinson and Company2025-07-02
LIAISON MUREX Anti-HBc and LIAISON MUREX Control Anti-HBc (P180038/S024)DiaSorin, Inc.2025-06-04
ADVIA Centaur HBsAgII (HBsII) (P110041/S014)Siemens Corp.2025-06-04
LIAISON QuantiFERON -TB Gold Plus and LIAISON Control QuantiFERON -TB Gold Plus (P180047/S035)DiaSorin, Inc.2025-06-04
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010)Roche Diagnostics2025-05-22
Elecsys Anti-HBc II (P100031/S033)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc II (P100032/S023)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc IgM (P110031/S027)Roche Diagnostics Corp.2025-05-22
Elecsys HBeAg (P130015/S022)Roche Diagnostics Operations, Inc.2025-05-22
Elecsys Anti-HBc IgM (P110022/S034)Roche Diagnostics Corp.2025-05-22
Elecsys HBsAg II/Elecsys HBsAg Auto Confirm (P160019/S019)Roche Diagnostics, Inc.2025-05-22
Elecsys Anti-HBe (P190005/S007)Roche Diagnostics2025-05-22
Elecsys Anti-HBs (P010054/S048)Roche Diagnostics Corp.2025-05-22
LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM (P180045/S017)DiaSorin, Inc.2025-04-25
LIAISON XL MUREX HBsAg Qual, LIAISON MUREX Control HBsAg, and LIAISON XL MUREX HBsAg Confirmatory Test (P190017/S023)DiaSorin, Inc.2025-04-25
LIAISON QuantiFERON - TB Gold Plus, LIAISON XL Control QuantiFERON - TB Gold Plus (P180047/S032)DiaSorin, Inc.2025-04-25
LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg (P180048/S018)DiaSorin, Inc.2025-04-25
LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe (P180049/S018)DiaSorin, Inc.2025-04-25
LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus (P220034/S004)DiaSorin, Inc.2025-04-25
LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc (P180038/S021)DiaSorin, Inc.2025-04-25
LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers (P180039/S020)DiaSorin, Inc.2025-04-25
MONOLISA ANTI-HBS EIA (P050048/S010)Bio-Rad Laboratories2025-04-18
Alinity m HR HPV (P230003/S007)Abbott Molecular, Inc.2025-04-18
Abbott RealTime HBV (P080026/S026)Abbott Molecular, Inc.2025-04-18
Alinity m HBV (P200013/S025)Abbott Molecular, Inc.2025-04-18
LIAISON® XL Murex HBsAg (REF 318250), LIAISON® Control XL Murex HBsAg (REF 318251) and LIAISON® XL Murex HBsAg Confirmat (P190017/S018)DiaSorin, Inc.2025-04-16
Alinity m HBV Assay (P200013/S024)Abbott Molecular, Inc.2025-04-11
Abbott RealTime HBV Assay (P080026/S025)Abbott Molecular, Inc.2025-04-11
LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software (P180047/S034)DiaSorin, Inc.2025-04-10
LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM (P180045/S019)DiaSorin, Inc.2025-04-10
LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc (P180038/S023)DiaSorin, Inc.2025-04-10
LIAISON XL MUREX Anti-HBe and LIAISON XL MUREX Control Anti-HBe (P180049/S020)DiaSorin, Inc.2025-04-10
LIAISON XL MUREX HBsAg Qual, LIAISON XL MUREX Control HBsAg Qual and LIAISON XL MUREX HBsAg Confirmatory (P190017/S025)DiaSorin, Inc.2025-04-10
LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers (P180039/S022)DiaSorin, Inc.2025-04-10
LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus (P220034/S006)DiaSorin, Inc.2025-04-10
LIAISON XL MUREX HBeAg and LIAISON XL MUREX Control HBeAg (P180048/S020)DiaSorin, Inc.2025-04-10
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT AUSAB; Alinity i Anti-HBs (P050051/S061)Abbott Laboratories, Inc.2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
T-SPOT TB (P070006/S024)Oxford Immunotec, Ltd.2025-03-31
cobas HPV TEST (P100020/S062)Roche Molecular Systems, Inc.2025-03-27
cobas HPV for use on the cobas 6800/8800 Systems (P190028/S019)Roche Molecular Systems, Inc.2025-03-27
Atellica IM Anti-HBe2 (aHBe2) (P200017/S003)Siemens Healthcare Diagnostics, Inc.2025-03-20
Onclarity HPV Assay (P160037/S021)Becton, Dickinson and Company2025-03-12
ADVIA Centaur HBsAgII (HBsII) and ADVIA Centaur HBsAgII Confirmatory (HBsII Conf) Assay (P110041/S015)Siemens Corp.2025-03-04
Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2); Atellica IM Anti-Hepatitis B surface Antigen 2 Quality Control ( (P100039/S016)Siemens Healthcare Diagnostics, Inc.2025-02-26
LIAISON XL MUREX HBeAg; vLIAISON XL MUREX Control HBeAg (P180048/S019)DiaSorin, Inc.2025-02-25
LIAISON XL MUREX HBsAg Qual; LIAISON XL MUREX Control HBsAg Qual; LIAISON XL MUREX HBsAg Confirmatory (P190017/S024)DiaSorin, Inc.2025-02-25
LIAISON MUREX Anti-HBc; LIAISON MUREX Control Anti-HBc (P180038/S022)DiaSorin, Inc.2025-02-25
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