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Data / Medical devices / Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase (CFJ): 30 FDA-registered makers in 10 countries

30 establishments in 10 countries are registered with the FDA to make Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase (product code CFJ, Class 2, 21 CFR 862.1440). 8 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 111 510(k) clearances under this code, the latest on October 2, 2013, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
CFJ
Device class
2
Regulation
862.1440
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States17
Ireland2
China2
France2
Germany2
United Kingdom1
Greece1
Switzerland1
Canada1
Argentina1

Makers of Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

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
Cliniqa CorporationSan Marcos, CA, United StatesManufacturer2June 16, 1983000api.fda.gov
Horiba Instruments IncorporatedCanton, MI, United StatesManufacturer2October 8, 1997010api.fda.gov
Abaxis, Inc.Union City, CA, United StatesManufacturer1July 8, 2005000api.fda.gov
Alfa WassermannWest Caldwell, NJ, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1October 2, 2013000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer, Manufacturer, Manufacturer for export1April 7, 1986000api.fda.gov
Infrared Laboratory Systems dba SYNERMEDWestfield, IN, United StatesManufacturer1March 23, 1992000api.fda.gov
Randox Laboratories LimitedCRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomContract manufacturer, Manufacturer1May 7, 1997000api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer1December 18, 1987000api.fda.gov
Abbott Ireland Diagnostics DivisionLongford, IrelandManufacturer0000api.fda.gov
Abbott LaboratoriesIrving, TX, United StatesSpecification developer0000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesManufacturer, Specification developer0010api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Biobase Biodustry(shandong)co., LtdJinan Shandong, ChinaManufacturer0000api.fda.gov
Beckman Coulter Ireland IncO CALLAGHANS MILLS Clare, IrelandContract manufacturer, Manufacturer0000api.fda.gov
Dirui Industrial Co., Ltd.CHANGCHUN Jilin, ChinaManufacturer0000api.fda.gov
Horiba Abx SASMONTPELLIER Herault, FranceSpecification developer0000api.fda.gov
High Technology, Inc.North Attleboro, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Medica Corp.Bedford, MA, United StatesManufacturer0000api.fda.gov
Medicon Hellas SAGERAKAS Attiki, GreeceManufacturer0000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer0010api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer0000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyExporter to the US, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Roche Diagnostics GMBHPENZBERG Bavaria, GermanyManufacturer0000api.fda.gov
Roche Diagnostics International Ltd.ROTKREUZ Zug, SwitzerlandManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer0020api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer0000api.fda.gov
Sekisui Diagnostics P.E.I. Inc.CHARLOTTETOWN Prince Edward Island, CanadaManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
VitalScientificSEES Normandie, FranceManufacturer0000api.fda.gov
Wiener Laboratorios S.A.I.C.ROSARIO Santa Fe, ArgentinaManufacturer0000api.fda.gov

Updated October 2, 2013. 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.