Atlas FDA

LOL

26 FDA 510(k) clearances · Product code

164 daysmedian time to decision
214 days90th percentile
26clearances measured

FDA profile

Official device name
Hepatitis A Test (Antibody And Igm Antibody)
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3310
Medical specialty
Microbiology
Adverse events (MAUDE)
2019: 51 · 2020: 104 · 2022: 17 · 2023: 36 · 2024: 21 · 2025: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Elecsys Anti-HAV IgM (K260048)Roche Diagnostics2026-04-07
Access anti-HAV IgM (K251995)Beckman Coulter, Inc.2026-01-27
Access anti-HAV (K243846)Beckman Coulter, Inc.2025-09-09
HAVAb IgG II (K222850)Abbott Laboratories2023-08-10
LIAISON Anti-HAV; LIAISON XS (K223403)DiaSorin, Inc.2022-12-09
LIAISON Anti-HAV (K210272)DiaSorin, Inc.2021-02-09
LIAISON Anti-HAV Assay (K193532)DiaSorin, Inc.2020-03-02
Elecsys Anti-HAV II (K190428)Roche Diagnostics2019-08-13
ADVIA Centaur HAV IgM Assay (K161964)Siemens Healthcare Diagnostics, Inc.2016-10-13
LIAISON HAV IgM, LIAISON Control HAV IgM (K160650)DiaSorin, Inc.2016-08-25
ADVIA Centaur HAV total assay (K142758)Siemens Healthcare Diagnostics, Inc.2014-12-05
LIAISON XL ANALYZER (K141116)DiaSorin, Inc.2014-07-25
ARCHITECT HAVAB-G (K113704)Abbott Laboratories2012-06-28
LIAISON XL ANALYZER MODEL 10050 (K103529)DiaSorin, Inc.2011-01-21
ANTI-HAV (K100903)Roche Professional Diagnostics2010-10-05
ANTI-HAV IGM (K093955)Roche Diagnostics2010-06-22
MONOLISA ANTI-HAV EIA (K092355)Bio-Rad Laboratories, Inc.2009-10-29
MONOLISA ANTI-HAV IGM EIA (K092353)Bio-Rad Laboratories, Inc.2009-10-29
LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV (K082049)DiaSorin, Inc.2008-12-05
LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM (K082050)DiaSorin, Inc.2008-11-03
ADVIA CENTAUR HAVM ASSAY (K081716)Siemens Healthcare Diagnostics, Inc.2008-07-17
MONOLISA ANTI-HAV EIA (K063318)Bio-Rad Laboratories2007-05-03
MONOLISA ANTI-HAV IGM EIA (K063319)Bio-Rad Laboratories2007-05-03
ABBOTT ARCHITECT HAVAB-M (K063329)Abbott Laboratories2007-04-16
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS (K060770)Ortho-Clinical Diagnostics, Inc.2006-09-15
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS (K060678)Ortho-Clinical Diagnostics, Inc.2006-09-14

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Every clearance here is in the API, with alerts when new ones post.