Product code LOL
- Device name
- Hepatitis A Test (Antibody And Igm Antibody)
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3310
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P890014S008 | ETI-HA-IGMK PLUS KIT | DiaSorin, Inc. | 2005-12-14 |
| P890019S012 | ETI-AB-HAVK PLUS | Diasorin | 2005-12-12 |
| P790019S020 | ABBOTT IMX HAVAB-M LIST 2263 | Abbott Laboratories | 2005-10-06 |
| P890019S011 | DIASORIN ETI-AB-HAVK PLUS | Diasorin | 2005-06-22 |
| P890014S007 | DIASORIN ETI-HA-IGMK PLUS | DiaSorin, Inc. | 2005-06-22 |
| P790019S019 | ABBOTT HAVAB -M EIA | Abbott Laboratories | 2005-05-25 |
| P040017 | ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS | Bayer Healthcare, Diagnostics Division | 2005-03-07 |
| P040018 | ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS | Bayer Healthcare, LLC | 2004-12-22 |
| P780012S014 | AXSYM HAVAB 2.0 | Abbott Laboratories | 2004-07-30 |
| P790019S018 | DEVICE: ABBOTT AXSYM HAVAB-M 2.0 | Abbott Laboratories | 2004-06-16 |
| P890019S009 | DIASORIN ETI-AB-HAVK PLUS ASSAY | Diasorin | 2004-02-20 |
| P790019S011 | ABBOTT AXSYM HAVAB-M 2.0 | Abbott Laboratories | 2004-02-02 |
| P780012S009 | ABBOTT AXSYM HAVAB 2.0 | Abbott Laboratories | 2004-02-02 |
| P790019S017 | IMX HAVAB -M (LIST NUMBER 2263) | Abbott Laboratories | 2003-11-06 |
| P890014S005 | DIASORIN ETI-HA-IGMK PLUS | DiaSorin, Inc. | 2003-05-06 |
| P890019S007 | DIASORIN ETI-AB-HAVK PLUS | Diasorin | 2002-11-08 |
| P890014S004 | ETI-HA-IGMK PLUS KIT | DiaSorin, Inc. | 2002-11-08 |
| P790019S016 | HAVAB-M EIA | Abbott Laboratories | 2002-11-06 |
| P790019S015 | IMX HAVAB-M | Abbott Laboratories | 2002-09-05 |
| P790019S014 | ABBOTT HAVAB-M 7180/ HAVAB-M EIA 9843/IMX HAVAB-M 2263 | Abbott Laboratories | 2002-09-05 |
| P790019S013 | ABBOTT HAVAB-M/HAVAB-M EIA/IMX HAVAB-M | Abbott Laboratories | 2002-09-05 |
| P790019S012 | HAVAB-M (R) EIA | Abbott Laboratories | 2002-09-05 |
| P780012S013 | IMX HAVAB | Abbott Laboratories | 2002-09-05 |
| P780012S012 | ABBOTT HAVAB/HAVAB EIA/IMX HAVAB | Abbott Laboratories | 2002-09-05 |
| P780012S011 | ABBOTT HAVAB/HAVAB EIA/IMX HAVAB | Abbott Laboratories | 2002-09-05 |
| P780012S010 | HAVAB (R) EIA | Abbott Laboratories | 2002-09-05 |
| P890019S006 | AB-HAVK RIA ASSAY/ETI-AB-HAVK PLUS | Diasorin | 2001-02-02 |
| P890014S003 | HA-IGMK RIA ASSAY/ETI-HA-IGMK PLUS | DiaSorin, Inc. | 2001-02-02 |
| P890019S005 | AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS | Diasorin | 1998-09-22 |
| P890014S002 | DIASORIN ETI-HA-IGMK PLUS | DiaSorin, Inc. | 1998-09-16 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260048 | Elecsys Anti-HAV IgM | Roche Diagnostics | 2026-04-07 |
| K251995 | Access anti-HAV IgM | Beckman Coulter, Inc. | 2026-01-27 |
| K243846 | Access anti-HAV | Beckman Coulter, Inc. | 2025-09-09 |
| K222850 | HAVAb IgG II | Abbott Laboratories | 2023-08-10 |
| K223403 | LIAISON Anti-HAV; LIAISON XS | DiaSorin, Inc. | 2022-12-09 |
| K210272 | LIAISON Anti-HAV | DiaSorin, Inc. | 2021-02-09 |
| K193532 | LIAISON Anti-HAV Assay | DiaSorin, Inc. | 2020-03-02 |
| K190428 | Elecsys Anti-HAV II | Roche Diagnostics | 2019-08-13 |
| K161964 | ADVIA Centaur HAV IgM Assay | Siemens Healthcare Diagnostics, Inc. | 2016-10-13 |
| K160650 | LIAISON HAV IgM, LIAISON Control HAV IgM | DiaSorin, Inc. | 2016-08-25 |
| K142758 | ADVIA Centaur HAV total assay | Siemens Healthcare Diagnostics, Inc. | 2014-12-05 |
| K141116 | LIAISON XL ANALYZER | DiaSorin, Inc. | 2014-07-25 |
| K113704 | ARCHITECT HAVAB-G | Abbott Laboratories | 2012-06-28 |
| K103529 | LIAISON XL ANALYZER MODEL 10050 | DiaSorin, Inc. | 2011-01-21 |
| K100903 | ANTI-HAV | Roche Professional Diagnostics | 2010-10-05 |
| K093955 | ANTI-HAV IGM | Roche Diagnostics | 2010-06-22 |
| K092355 | MONOLISA ANTI-HAV EIA | Bio-Rad Laboratories, Inc. | 2009-10-29 |
| K092353 | MONOLISA ANTI-HAV IGM EIA | Bio-Rad Laboratories, Inc. | 2009-10-29 |
| K082049 | LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV | DiaSorin, Inc. | 2008-12-05 |
| K082050 | LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM | DiaSorin, Inc. | 2008-11-03 |
| K081716 | ADVIA CENTAUR HAVM ASSAY | Siemens Healthcare Diagnostics, Inc. | 2008-07-17 |
| K063319 | MONOLISA ANTI-HAV IGM EIA | Bio-Rad Laboratories | 2007-05-03 |
| K063318 | MONOLISA ANTI-HAV EIA | Bio-Rad Laboratories | 2007-05-03 |
| K063329 | ABBOTT ARCHITECT HAVAB-M | Abbott Laboratories | 2007-04-16 |
| K060770 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS | Ortho-Clinical Diagnostics, Inc. | 2006-09-15 |
| K060678 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS | Ortho-Clinical Diagnostics, Inc. | 2006-09-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 15099590806446 | Access anti-HAV IgM | Beckman Coulter, Inc. | 2026-04-23 |
| 00380740197650 | Alinity | Abbott GmbH | 2023-11-04 |
| 00630414301297 | Atellica IM aHAVT | Siemens Healthcare Diagnostics Inc. | 2021-01-15 |
| 00630414301259 | Atellica IM aHAVM | Siemens Healthcare Diagnostics Inc. | 2021-01-15 |
| 00380740136628 | Alinity | Abbott GmbH | 2020-12-23 |
| 00380740131371 | Alinity | Abbott GmbH | 2020-11-06 |
| 00380740136611 | Alinity | Abbott GmbH | 2020-01-06 |
| 00380740131579 | Alinity | Abbott GmbH | 2020-01-06 |
| 00380740131562 | Alinity | Abbott GmbH | 2020-01-06 |
| 07613336129722 | Elecsys Anti-HAV II | Roche Diagnostics GmbH | 2019-09-30 |
| 07613336129715 | Elecsys Anti-HAV II | Roche Diagnostics GmbH | 2019-09-30 |
| 04015630939855 | Elecsys Anti-HAV IgM | Roche Diagnostics GmbH | 2017-09-07 |
| 04015630939916 | Elecsys Anti-HAV | Roche Diagnostics GmbH | 2017-06-20 |
| 00630414479996 | ADVIA Centaur® HAV IgM | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414480008 | ADVIA Centaur® HAV IgM QC | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414481876 | ADVIA Centaur® aHAVT | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414481883 | ADVIA Centaur® Systems QC aHAVT | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 08056771100205 | LIAISON® Control anti-HAV | DIASORIN SPA | 2016-09-24 |
| 08056771100199 | LIAISON® anti-HAV | DIASORIN SPA | 2016-09-24 |
| 04015630938858 | Elecsys AntiHAV IgM | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630938841 | Elecsys AntiHAV Assay | Roche Diagnostics GmbH | 2016-09-20 |
| 00847865012362 | MONOLISA | BIO-RAD | 2016-09-12 |
| 00847865012379 | MONOLISA | BIO-RAD | 2016-09-12 |
| 00380740011185 | ARCHITECT | Abbott GmbH | 2016-09-09 |
| 00380740011178 | ARCHITECT | Abbott GmbH | 2016-09-09 |
| 00380740011161 | ARCHITECT | Abbott GmbH | 2016-09-09 |
| 10758750008926 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2016-08-26 |
| 10758750001477 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2016-08-26 |
| 10758750001415 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2016-08-26 |
| 10758750001286 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2016-08-26 |