Product code LOL— Microbiology

FDA has cleared 26 devices under product code LOL between 2006 and 2026, filed by 9 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20262 clearances
• 20251 clearance
• 20231 clearance
• 20221 clearance
• 20211 clearance
• 20201 clearance
• 20191 clearance
• 20162 clearances
• 20142 clearances
• 20121 clearance
• 20111 clearance
• 20102 clearances
• 20092 clearances
• 20083 clearances
• 20073 clearances

• DiaSorin, Inc.8 clearances
• Siemens Healthcare Diagnostics, Inc.3 clearances
• Roche Diagnostics3 clearances
• Abbott Laboratories3 clearances
• Ortho-Clinical Diagnostics, Inc.2 clearances
• Bio-Rad Laboratories, Inc.2 clearances
• Bio-Rad Laboratories2 clearances
• Beckman Coulter, Inc.2 clearances
• Roche Professional Diagnostics1 clearance

• K260048 — Elecsys Anti-HAV IgMRoche Diagnostics·2026-04-07
• K251995 — Access anti-HAV IgMBeckman Coulter, Inc.·2026-01-27
• K243846 — Access anti-HAVBeckman Coulter, Inc.·2025-09-09
• K222850 — HAVAb IgG IIAbbott Laboratories·2023-08-10
• K223403 — LIAISON Anti-HAV; LIAISON XSDiaSorin, Inc.·2022-12-09
• K210272 — LIAISON Anti-HAVDiaSorin, Inc.·2021-02-09
• K193532 — LIAISON Anti-HAV AssayDiaSorin, Inc.·2020-03-02
• K190428 — Elecsys Anti-HAV IIRoche Diagnostics·2019-08-13
• K161964 — ADVIA Centaur HAV IgM AssaySiemens Healthcare Diagnostics, Inc.·2016-10-13
• K160650 — LIAISON HAV IgM, LIAISON Control HAV IgMDiaSorin, Inc.·2016-08-25
• K142758 — ADVIA Centaur HAV total assaySiemens Healthcare Diagnostics, Inc.·2014-12-05
• K141116 — LIAISON XL ANALYZERDiaSorin, Inc.·2014-07-25
• K113704 — ARCHITECT HAVAB-GAbbott Laboratories·2012-06-28
• K103529 — LIAISON XL ANALYZER MODEL 10050DiaSorin, Inc.·2011-01-21
• K100903 — ANTI-HAVRoche Professional Diagnostics·2010-10-05
• K093955 — ANTI-HAV IGMRoche Diagnostics·2010-06-22
• K092353 — MONOLISA ANTI-HAV IGM EIABio-Rad Laboratories, Inc.·2009-10-29
• K092355 — MONOLISA ANTI-HAV EIABio-Rad Laboratories, Inc.·2009-10-29
• K082049 — LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAVDiaSorin, Inc.·2008-12-05
• K082050 — LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGMDiaSorin, Inc.·2008-11-03
• K081716 — ADVIA CENTAUR HAVM ASSAYSiemens Healthcare Diagnostics, Inc.·2008-07-17
• K063318 — MONOLISA ANTI-HAV EIABio-Rad Laboratories·2007-05-03
• K063319 — MONOLISA ANTI-HAV IGM EIABio-Rad Laboratories·2007-05-03
• K063329 — ABBOTT ARCHITECT HAVAB-MAbbott Laboratories·2007-04-16
• K060770 — VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLSOrtho-Clinical Diagnostics, Inc.·2006-09-15
• K060678 — VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLSOrtho-Clinical Diagnostics, Inc.·2006-09-14