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Data / Medical devices / Hepatitis A Test (Antibody And Igm Antibody)

Hepatitis A Test (Antibody And Igm Antibody) (LOL): 17 FDA-registered makers in 6 countries

17 establishments in 6 countries are registered with the FDA to make Hepatitis A Test (Antibody And Igm Antibody) (product code LOL, Class 2, 21 CFR 866.3310). 11 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 26 510(k) clearances under this code, the latest on April 7, 2026, and lists 11 recall events (0 Class I). FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
LOL
Device class
2
Regulation
866.3310
Medical specialty
Microbiology

Makers by country

CountryMakers
United States8
Germany3
France2
United Kingdom2
Italy1
Ireland1

Makers of Hepatitis A Test (Antibody And Igm Antibody)

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
DiaSorin Italia S.p.A.SALUGGIA Vercelli, ItalyManufacturer, Specification developer5March 2, 2020000api.fda.gov
Bio-RadSTEENVOORDE Nord, FranceManufacturer4October 29, 2009000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer2October 13, 2016200api.fda.gov
ABBOTT GmbHWiesbaden Hesse, GermanyManufacturer3August 10, 2023020api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyManufacturer3April 7, 2026000api.fda.gov
Immunotech SAS, a Beckman Coulter companyMARSEILLE, CEDEX 9 Bouches-du-Rhone, FranceSpecification developer2January 27, 2026000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer2September 15, 2006000api.fda.gov
Ortho-Clinical DiagnosticsPencoed Bridgend, United KingdomManufacturer2September 15, 2006000api.fda.gov
Siemens Healthcare Diagnostics IncEast Walpole, MA, United StatesManufacturer2October 13, 2016000api.fda.gov
Siemens Healthcare Diagnostics Inc.E Walpole, MA, United StatesManufacturer0210api.fda.gov
Diasorin Inc.Stillwater, MN, United StatesManufacturer1March 2, 2020010api.fda.gov
Beckman Coulter Ireland IncO CALLAGHANS MILLS Clare, IrelandContract manufacturer0000api.fda.gov
CTK Biotech, Inc.Poway, CA, United StatesManufacturer for export0000api.fda.gov
DiaSorin Deutschland GmbHDietzenbach Hesse, GermanyContract manufacturer0000api.fda.gov
DiaSorin Italia S.p.A UK BranchDartford Kent, United KingdomContract manufacturer0000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer, Manufacturer for export, Repackager or relabeler0000api.fda.gov
Epitope Diagnostics, Inc.San Diego, CA, United StatesManufacturer for export0000api.fda.gov

Updated April 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.