Panels › Microbiology › Product code LOL · Class 2
Hepatitis A Test (Antibody And Igm Antibody)
Regulation 866.3310
2510(k)s in 12 months (26 all time)
0recalls in 12 months (12 all time)
7recalls that name a 510(k)
Top companies in LOL
| Company | 510(k)s | Recalls |
|---|---|---|
| DiaSorin, Inc. | 8 | 1 |
| Abbott Laboratories | 3 | 3 |
| Bio-Rad Laboratories | 4 | 0 |
| Roche Diagnostics | 3 | 1 |
| Siemens Healthcare Diagnostics, Inc. | 3 | 0 |
| Abbott Gmbh & Co. KG | 0 | 2 |
| Abbott Health Products, Inc. | 0 | 2 |
| Beckman Coulter, Inc. | 2 | 0 |
| Ortho-Clinical Diagnostics, Inc. | 2 | 0 |
| Abbott Diagnostics International, Ltd. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 7, 2026 | K260048 | Elecsys Anti-HAV IgM Roche Diagnostics | LOL |
| Jan 27, 2026 | K251995 | Access anti-HAV IgM Beckman Coulter, Inc. | LOL |
| Sep 9, 2025 | K243846 | Access anti-HAV Beckman Coulter, Inc. | LOL |
| Aug 10, 2023 | K222850 | HAVAb IgG II Abbott Laboratories | LOL |
| Dec 9, 2022 | K223403 | LIAISON Anti-HAV; LIAISON XS DiaSorin, Inc. | LOL |
| Feb 9, 2021 | K210272 | LIAISON Anti-HAV DiaSorin, Inc. | LOL |
| Mar 2, 2020 | K193532 | LIAISON Anti-HAV Assay DiaSorin, Inc. | LOL |
| Aug 13, 2019 | K190428 | Elecsys Anti-HAV II Roche Diagnostics | LOL |
| Oct 13, 2016 | K161964 | ADVIA Centaur HAV IgM Assay Siemens Healthcare Diagnostics, Inc. | LOL |
| Aug 25, 2016 | K160650 | LIAISON HAV IgM, LIAISON Control HAV IgM DiaSorin, Inc. | LOL |
| Dec 5, 2014 | K142758 | ADVIA Centaur HAV total assay Siemens Healthcare Diagnostics, Inc. | LOL |
| Jul 25, 2014 | K141116 | LIAISON XL ANALYZER DiaSorin, Inc. | LOL |
| Jun 28, 2012 | K113704 | ARCHITECT HAVAB-G Abbott Laboratories | LOL |
| Jan 21, 2011 | K103529 | LIAISON XL ANALYZER MODEL 10050 DiaSorin, Inc. | LOL |
| Oct 5, 2010 | K100903 | ANTI-HAV Roche Professional Diagnostics | LOL |
| Jun 22, 2010 | K093955 | ANTI-HAV IGM Roche Diagnostics | LOL |
| Oct 29, 2009 | K092355 | MONOLISA ANTI-HAV EIA Bio-Rad Laboratories, Inc. | LOL |
| Oct 29, 2009 | K092353 | MONOLISA ANTI-HAV IGM EIA Bio-Rad Laboratories, Inc. | LOL |
| Dec 5, 2008 | K082049 | LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV DiaSorin, Inc. | LOL |
| Nov 3, 2008 | K082050 | LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM DiaSorin, Inc. | LOL |
| Jul 17, 2008 | K081716 | ADVIA CENTAUR HAVM ASSAY Siemens Healthcare Diagnostics, Inc. | LOL |
| May 3, 2007 | K063319 | MONOLISA ANTI-HAV IGM EIA Bio-Rad Laboratories, FR | LOL |
| May 3, 2007 | K063318 | MONOLISA ANTI-HAV EIA Bio-Rad Laboratories, FR | LOL |
| Apr 16, 2007 | K063329 | ABBOTT ARCHITECT HAVAB-M Abbott Laboratories | LOL |
| Sep 15, 2006 | K060770 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS Ortho-Clinical Diagnostics, Inc. | LOL |
| Sep 14, 2006 | K060678 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS Ortho-Clinical Diagnostics, Inc. | LOL |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.