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Data / Medical devices / System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (LON): 16 FDA-registered makers in 5 countries

16 establishments in 5 countries are registered with the FDA to make System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (product code LON, Class 2, 21 CFR 866.1645). 7 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 291 510(k) clearances under this code, the latest on October 1, 2026, and lists 45 recall events (4 Class I). FDA data exported November 2, 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
LON
Device class
2
Regulation
866.1645
Medical specialty
Microbiology

Makers by country

CountryMakers
United States11
Italy2
Hungary1
Mexico1
Sweden1

Makers of System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

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
Biomerieux, Inc.Hazelwood, MO, United StatesManufacturer, Manufacturer for export, Specification developer111October 1, 20260161api.fda.gov
Becton, Dickinson & Co.Sparks, MD, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Specification developer109August 8, 20250150api.fda.gov
Becton, Dickinson & Co.Cockeysville, MD, United StatesManufacturer2April 29, 2005000api.fda.gov
Becton, Dickinson and CompanyMebane, NC, United StatesManufacturer2April 29, 2005000api.fda.gov
Beckman Coulter, Inc.West Sacramento, CA, United StatesContract manufacturer, Manufacturer, Manufacturer for export1August 30, 2020042api.fda.gov
Copan WASPBrescia Lombardy, ItalyManufacturer, Specification developer1December 27, 2023000api.fda.gov
Trinity Biotech USAJamestown, NY, United StatesManufacturer1November 26, 2003000api.fda.gov
Affinity BiosensorsSanta Barbara, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Copan ItaliaBRESCIA Lombardy, ItalyContract manufacturer0000api.fda.gov
DIAMOND DIAGNOSTICS IncHolliston, MA, United StatesContract manufacturer0000api.fda.gov
Diamond Diagnostics Inc.Budapest, HungaryContract manufacturer0000api.fda.gov
Hach CompanyAmes, IA, United StatesContract manufacturer0000api.fda.gov
Hardy DiagnosticsOrcutt, CA, United StatesContract manufacturer0000api.fda.gov
Laboratorios PiSA, S. A. de C.V.Tlajomulco de Zuniga Jalisco, MexicoContract manufacturer, Contract sterilizer0000api.fda.gov
Q-linea ABUppsala, SwedenComplaint file establishment, Manufacturer0000api.fda.gov
VorzeigenConnersville, IN, United StatesContract manufacturer0000api.fda.gov

Updated October 1, 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.