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Data / Medical devices / Kinetic Method, Gamma-Glutamyl Transpeptidase

Kinetic Method, Gamma-Glutamyl Transpeptidase (JQB): 25 FDA-registered makers in 9 countries

25 establishments in 9 countries are registered with the FDA to make Kinetic Method, Gamma-Glutamyl Transpeptidase (product code JQB, Class 1, 21 CFR 862.1360). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 52 510(k) clearances under this code, the latest on November 4, 1997, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
JQB
Device class
1
Regulation
862.1360
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States15
Germany2
France2
Canada1
Ireland1
Egypt1
Switzerland1
Argentina1
China1

Makers of Kinetic Method, Gamma-Glutamyl Transpeptidase

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 StatesManufacturer1December 20, 1990000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesManufacturer1November 19, 1991000api.fda.gov
Horiba Instruments IncorporatedCanton, MI, United StatesManufacturer1October 10, 1997000api.fda.gov
Infrared Laboratory Systems dba SYNERMEDWestfield, IN, United StatesManufacturer1September 8, 1993000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyExporter to the US, Manufacturer, Repackager or relabeler1January 13, 1997000api.fda.gov
Sekisui Diagnostics P.E.I. Inc.CHARLOTTETOWN Prince Edward Island, CanadaManufacturer1November 4, 1997000api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer1May 27, 1988000api.fda.gov
Abaxis, Inc.Union City, CA, United StatesManufacturer0000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Bialex LabWichita Falls, TX, United StatesManufacturer, Manufacturer for export0000api.fda.gov
Beckman Coulter Ireland IncO CALLAGHANS MILLS Clare, IrelandManufacturer0000api.fda.gov
Elhoda Trade And SuppliesBadr industerial city Al Qahirah, EgyptManufacturer0000api.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
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer0000api.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 developer0000api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer0000api.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
Zhejiang Orient Gene BiotechHuzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov

Updated November 4, 1997. 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.