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Data / Medical devices / Campylobacter Spp.

Campylobacter Spp. (LQP): 17 FDA-registered makers in 4 countries

17 establishments in 4 countries are registered with the FDA to make Campylobacter Spp. (product code LQP, Class 1, 21 CFR 866.3110). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on December 23, 2021, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code
LQP
Device class
1
Regulation
866.3110
Medical specialty
Microbiology

Makers by country

CountryMakers
United States10
United Kingdom3
Mexico3
Germany1

Makers of Campylobacter Spp.

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
Meridian Bioscience, Inc.Cincinnati, OH, United StatesComplaint file establishment, Manufacturer3December 23, 2021000api.fda.gov
Techlab, Inc.Radford, VA, United StatesManufacturer2January 22, 2018000api.fda.gov
Techlab, Inc.Blacksburg, VA, United StatesManufacturer2January 22, 2018000api.fda.gov
Oxoid, Ltd.Basingstoke, Hampshire, United KingdomExporter to the US, Specification developer1November 18, 1998000api.fda.gov
Ortho-Clinical Diagnostics, Inc.San Diego, CA, United StatesSpecification developer1November 23, 2021000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Carlsbad, CA, United StatesManufacturer1November 23, 2021000api.fda.gov
Quidel Corp.San Diego, CA, United StatesComplaint file establishment, Manufacturer1November 23, 2021000api.fda.gov
Bbi Solutions Oem LimitedCrumlin Newport, United KingdomContract manufacturer0000api.fda.gov
Diasorin Inc.Stillwater, MN, United StatesManufacturer for export0000api.fda.gov
Laboratorios Scantibodies S.A. De C.V.TECATE Baja California, MexicoContract manufacturer0000api.fda.gov
Laboratorios Scantibodies, S.A. de C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Laboratorios Scantibodies, S.A. de C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Merck KgaaDARMSTADT Hesse, GermanyContract manufacturer0000api.fda.gov
Remel Europe LtdDartford, Kent, United KingdomContract manufacturer0000api.fda.gov
Scantibodies Laboratory Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
Scantibodies Laboratory, Inc.Santee, CA, United StatesContract manufacturer0000api.fda.gov
Victorch Meditek, Inc.San Diego, CA, United StatesManufacturer for export0000api.fda.gov

Updated December 23, 2021. 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.