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Microbiology

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

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RecordFirmDate
BD Onclarity™ HPV Assay (P160037/S011)Becton, Dickinson and Company2022-11-19
cobas® HPV (P100020/S054)Roche Molecular Systems, Inc.2022-11-14
COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test (P110037/S057)Roche Molecular Systems, Inc.2022-11-14
COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0 (P050028/S086)Roche Molecular Systems, Inc.2022-11-14
Alinity i Anti-HBc (List Number 07P84) (P080023/S038)Abbott Laboratories2022-10-25
Alinity i Anti-HBc IgM (List Number 07P86) (P060035/S036)Abbott Laboratories2022-10-25
Alinity m HBV (P200013/S009)Abbott Molecular, Inc.2022-10-24
IMMULITE® 2000 Anti-HBs (P010052/S016)Siemens Healthcare Diagnostics Products, Ltd.2022-10-14
IMMULITE® 2000 Anti-HBc (P010051/S017)Siemens Healthcare Diagnostics Products, Ltd.2022-10-14
IMMULITE® 2000 HBsAg and IMMULITE® 2000 HBsAg Confirmatory Kit’ (P010050/S021)Siemens Healthcare Diagnostics Products, Ltd.2022-10-14
IMMULITE® 2000 Anti-HBc IgM (P010053/S016)Siemens Healthcare Diagnostics Products, Ltd.2022-10-14
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S035)Abbott Laboratories2022-10-12
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S039)Abbott Laboratories2022-10-12
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S037)Abbott Laboratories2022-10-12
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory (P210003/S002)Abbott Laboratories2022-10-12
ARCHITECT AUSAB / Alinity i Anti-HBs (P050051/S047)Abbott Laboratories, Inc.2022-10-12
ARCHITECT AUSAB / Alinity i Anti-HBs (P050051/S046)Abbott Laboratories, Inc.2022-09-30
ARCHITECT HBsAg Next Qualitative/ Next Confirmatory (P210003/S001)Abbott Laboratories2022-09-30
ARCHITECT HBsAg Qualitative/Confirmatory/Alinity i HBsAg Qualitative II/Confirmatory (P110029/S038)Abbott Laboratories2022-09-30
T-SPOT. TB Test (P070006/S015)Oxford Immunotec, Ltd.2022-08-29
LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus (P180047/S018)DiaSorin, Inc.2022-08-11
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory, Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S037)Abbott Laboratories2022-08-10
ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT Qualit (P210003)Abbott Laboratories2022-08-10
ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2) (P210019)Siemens Healthcare Diagnostics, Inc.2022-07-27
Aptima HBV Quant Assay (P170025/S018)Hologic, Inc.2022-07-20
Aptima CMV Quant Assay (P210029/S001)Hologic, Inc.2022-07-20
LIAISON® QuantiFERON TB-Gold Plus assay and Control (P180047/S017)DiaSorin, Inc.2022-07-08
Alinity m HBV assay (P200013/S007)Abbott Molecular, Inc.2022-06-28
LIAISON® XL MUREX HBeAg assay and Control (P180048/S009)DiaSorin, Inc.2022-06-23
LIAISON® XL MUREX HBsAg Qual assay and Control (P190017/S006)DiaSorin, Inc.2022-06-23
LIAISON® XL MUREX Anti-HBc assay and Control (P180038/S012)DiaSorin, Inc.2022-06-23
LIAISON® XL MUREX Anti-HBe assay and Control (P180049/S009)DiaSorin, Inc.2022-06-23
LIAISON® XL MUREX Anti-HBs assay, Control and Verifiers (P180039/S011)DiaSorin, Inc.2022-06-23
LIAISON® QuantiFERON TB-Gold Plus assay and Control (P180047/S016)DiaSorin, Inc.2022-06-23
LIAISON® XL MUREX HBc IgM assay and Control (P180045/S009)DiaSorin, Inc.2022-06-23
Abbott RealTime CMV Amplification Kit (09N21-090), Abbott RealTime CMV Control Kit (09N21-080), Abbott RealTime CMV Cali (P160044/S004)Abbott Molecular2022-06-09
Alinity m HBV (P200013/S008)Abbott Molecular, Inc.2022-06-08
Alinity m CMV (P210022/S001)Abbott Molecular, Inc.2022-05-26
Aptima CMV Quant Assay (P210029)Hologic, Inc.2022-05-09
LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (P180045/S008)DiaSorin, Inc.2022-05-06
LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control Anti-HBc (P180038/S011)DiaSorin, Inc.2022-05-06
LIAISON® QuantiFERON-TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S015)DiaSorin, Inc.2022-05-06
LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifier (P180039/S010)DiaSorin, Inc.2022-05-06
LIAISON® XL MUREX HBeAg and LIAISON00 XL MUREX Control HBeAg (P180048/S008)DiaSorin, Inc.2022-05-06
LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual (P190017/S005)DiaSorin, Inc.2022-05-06
LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S008)DiaSorin, Inc.2022-05-06
LIAISON® XL MUREX Anti-HBe assay and Control (P180049/S007)DiaSorin, Inc.2022-05-05
LIAISON® XL MUREX Anti-HBs assay, Control and Verifiers (P180039/S009)DiaSorin, Inc.2022-05-05
LIAISON® XL MUREX HBsAg Qual assay and Control (P190017/S004)DiaSorin, Inc.2022-05-05
LIAISON® XL MUREX HBc lgM assay and Control (P180045/S007)DiaSorin, Inc.2022-05-05
Alinity m CMV (P210022)Abbott Molecular, Inc.2022-05-05
LIAISON® QuantiFERON TB-Gold Plus assay and Control (P180047/S014)DiaSorin, Inc.2022-05-05
LIAISON® XL MUREX HBeAg assay and Control (P180048/S007)DiaSorin, Inc.2022-05-05
LIAISON®XL MUREX Anti-HBc assay and Control (P180038/S010)DiaSorin, Inc.2022-05-05
ARCHITECT AUSAB, Alinity i Anti-HBs (P050051/S043)Abbott Laboratories, Inc.2022-04-14
Elecsys Anti-HBc II (P100031/S027)Roche Diagnostics Corp.2022-04-04
Elecsys Anti-HBc II (P100032/S021)Roche Diagnostics Corp.2022-04-04
Atellica® IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay (P100039/S015)Siemens Healthcare Diagnostics, Inc.2022-03-29
Atellica® IM Hepatitis B surface Antigen II (HBsll), Atellica® IM Hepatitis B surface Antigen 11 Confirmatory (HBsll Con (P110041/S013)Siemens Corp.2022-03-29
Atellica® IM Anti-Hepatitis B core Total (HBcT) Assay (P040004/S021)Siemens Healthcare Diagnostics2022-03-29
IMMULITE 2000 Anti-HBc (P010051/S015)Siemens Healthcare Diagnostics Products, Ltd.2022-03-29
Atellica® IM Hepatitis B core IgM (aHBcM) Assay (P030040/S021)Siemens Healthcare Diagnostics2022-03-29
Atellica® IM Hepatitis B e Antigen (HBeAg) Assay (P090024/S011)Siemens Healthcare Diagnostics2022-03-29
Atellica® IM Anti-HBe2 Assay (P200017/S002)Siemens Healthcare Diagnostics, Inc.2022-03-29
IMMULITE 2000 Anti-HBc IgM (P010053/S014)Siemens Healthcare Diagnostics Products, Ltd.2022-03-29
Alinity m HBV (P200013/S006)Abbott Molecular, Inc.2022-03-14
Aptima HBV Quant Assay (P170025/S017)Hologic, Inc.2022-02-25
Aptima HPV Assay (P100042/S032)Gen-Probe Incorporated2022-02-25
Aptima HPV 16 18/45 Genotype Assay (P120007/S029)Gen-Probe Incorporated2022-02-25
ADVIA Centaur anti-HBs2 (aHBs2), Atellica IM aHBs2 (P100039/S014)Siemens Healthcare Diagnostics, Inc.2022-02-16
Aptima HPV Assay (P100042/S033)Gen-Probe Incorporated2022-01-28
BD Onclarity™ HPV Assay (P160037/S010)Becton, Dickinson and Company2022-01-24
LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers (P180039/S005)DiaSorin, Inc.2022-01-21
LIAISON® XL MUREX HBsAg Qual, LIAISON® XL MUREX Control HBsAg Qual (P190017/S003)DiaSorin, Inc.2022-01-21
LIAISON® XL MUREX Anti-HBe, LIAISON® XL MUREX Control Anti-HBe (P180049/S003)DiaSorin, Inc.2022-01-21
LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM (P180045/S003)DiaSorin, Inc.2022-01-21
LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg (P180048/S003)DiaSorin, Inc.2022-01-21
LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus (P180047/S011)DiaSorin, Inc.2022-01-21
LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control Anti-HBC (P180038/S006)DiaSorin, Inc.2022-01-21
Roche Cobas HBV (P150014/S042)Roche Molecular Systems, Inc.2022-01-19
Cobas HPV (P190028/S006)Roche Molecular Systems, Inc.2022-01-19
Cobas CMV (P160041/S034)Roche Molecular Systems, Inc.2022-01-19
Elecsys Anti-HBs (P010054/S042)Roche Diagnostics Corp.2022-01-11
Elecsys Anti-HBc IgM Immunoassays (P110022/S028)Roche Diagnostics Corp.2022-01-11
ADVIA Centaur Anti-HBe2 (AHBe2) Assay (P200017/S001)Siemens Healthcare Diagnostics, Inc.2022-01-06
LIAISON® XL Murex Anti-HBe and LIAISON® XL Murex Control Anti-HBe (P180049/S005)DiaSorin, Inc.2021-12-27
LIAISON® XL Murex HBeAg and LIAISON® XL Murex Control HBeAg (P180048/S005)DiaSorin, Inc.2021-12-27
LIAISON® XL Murex Anti-HBc and LIAISON® XL Murex Control Anti-HBc (P180038/S008)DiaSorin, Inc.2021-12-27
LIAISON® XL Murex Anti-HBs, LIAISON® XL Murex Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers (P180039/S007)DiaSorin, Inc.2021-12-27
LIAISON® XL Murex HBc IgM and LIAISON® XL Murex Control HBc IgM (P180045/S005)DiaSorin, Inc.2021-12-27
ETI-AB-EBK PLUS assay (P990041/S031)DiaSorin, Inc.2021-12-21
Parvovirus B19 IgG Enzyme Immunoassay (P970054/S020)Diasorin2021-12-21
ETI-AB-COREK PLUS assay (P990045/S029)DiaSorin, Inc.2021-12-21
LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S004)DiaSorin, Inc.2021-12-21
LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (P180048/S004)DiaSorin, Inc.2021-12-21
ETI-EBK PLUS assay (P990043/S032)DiaSorin, Inc.2021-12-21
ETI-MAK-2 PLUS and HBsAg Confirmatory Test assay (P990038/S032)DiaSorin, Inc.2021-12-21
ETI-AB-AUK PLUS assay (P990042/S028)DiaSorin, Inc.2021-12-21
LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (P180045/S004)DiaSorin, Inc.2021-12-21
Parvovirus B19 IgM Enzyme Immunoassay (P970055/S022)Diasorin2021-12-21
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