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Data / Medical devices / Nadh Oxidation/Nad Reduction, Ast/Sgot

Nadh Oxidation/Nad Reduction, Ast/Sgot (CIT): 42 FDA-registered makers in 14 countries

42 establishments in 14 countries are registered with the FDA to make Nadh Oxidation/Nad Reduction, Ast/Sgot (product code CIT, Class 2, 21 CFR 862.1100). 17 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 139 510(k) clearances under this code, the latest on September 20, 2010, and lists 11 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
CIT
Device class
2
Regulation
862.1100
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States20
Japan4
Germany2
France2
Ireland2
United Kingdom2
China2
India2
Argentina1
Switzerland1
Canada1
Egypt1
Greece1
Netherlands1

Makers of Nadh Oxidation/Nad Reduction, Ast/Sgot

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
Abbott LaboratoriesIrving, TX, United StatesSpecification developer2March 19, 2008000api.fda.gov
Horiba Instruments IncorporatedCanton, MI, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler2December 21, 2001020api.fda.gov
Nittobo Medical Co., Ltd. Medical Development CenterKoriyama Fukushima, JapanManufacturer2March 19, 2008000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyExporter to the US, Manufacturer, Repackager or relabeler, Specification developer2July 30, 2007000api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer2June 29, 1998000api.fda.gov
VitalScientificSEES Normandie, FranceManufacturer2September 20, 2010010api.fda.gov
Wiener Laboratorios S.A.I.C.ROSARIO Santa Fe, ArgentinaManufacturer2December 9, 2002000api.fda.gov
Bialex LabWichita Falls, TX, United StatesManufacturer1December 22, 1981000api.fda.gov
Beckman Coulter Ireland IncO CALLAGHANS MILLS Clare, IrelandManufacturer1January 26, 1993000api.fda.gov
Cliniqa CorporationSan Marcos, CA, United StatesManufacturer1February 18, 1982000api.fda.gov
Carolina Liquid ChemistriesBrea, CA, United StatesManufacturer1January 17, 1997000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer, Manufacturer, Manufacturer for export1May 23, 1996000api.fda.gov
Horiba Abx SASMONTPELLIER Herault, FranceSpecification developer1August 8, 2006000api.fda.gov
Infrared Laboratory Systems dba SYNERMEDWestfield, IN, United StatesManufacturer1January 27, 1992000api.fda.gov
Randox Laboratories LimitedCRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomContract manufacturer, Manufacturer1November 16, 1992000api.fda.gov
Roche Diagnostics International Ltd.ROTKREUZ Zug, SwitzerlandManufacturer1July 30, 2007000api.fda.gov
Sekisui Diagnostics P.E.I. Inc.CHARLOTTETOWN Prince Edward Island, CanadaManufacturer1November 13, 1997000api.fda.gov
Abaxis, Inc.Union City, CA, United StatesManufacturer0000api.fda.gov
Abbott Ireland Diagnostics DivisionLongford, IrelandManufacturer, Repackager or relabeler0000api.fda.gov
Alfa WassermannWest Caldwell, NJ, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0010api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer0000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Biobase Biodustry(shandong)co., LtdJinan Shandong, ChinaManufacturer0000api.fda.gov
Beckman Coulter K. K.Sunto-Gun Shizuoka, JapanSpecification developer0000api.fda.gov
Beckman Coulter Mishima K.K.SUNTO-GUN Shizuoka, JapanContract manufacturer0000api.fda.gov
Dirui Industrial Co., Ltd.CHANGCHUN Jilin, ChinaManufacturer0000api.fda.gov
Elhoda Trade And SuppliesBadr industerial city Al Qahirah, EgyptManufacturer0000api.fda.gov
ELITechGroup IncLogan, UT, United StatesContract manufacturer0000api.fda.gov
Furuno Electric Co., Ltd.NISHINOMIYA-CITY Hyogo, JapanContract manufacturer, Manufacturer0000api.fda.gov
High Technology, Inc.North Attleboro, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Lords Mark Industries Ltd.Daman and Diu Dadra and Nagar Haveli, IndiaManufacturer0000api.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 StatesManufacturer, Manufacturer for export0000api.fda.gov
Q-Line Biotech LimitedLucknow Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Randox Laboratories LimitedANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomManufacturer0000api.fda.gov
Roche Diagnostics GMBHPENZBERG Bavaria, GermanyManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer0000api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer0010api.fda.gov
VitalScientific B.V.SPANKEREN Gelderland, NetherlandsManufacturer0000api.fda.gov

Updated September 20, 2010. 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.