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Data / Medical devices / Colorimetric Method, Gamma-Glutamyl Transpeptidase / United States

FDA-registered makers of Colorimetric Method, Gamma-Glutamyl Transpeptidase in the United States: 9 establishments

9 establishments in the United States are registered with the FDA to make Colorimetric Method, Gamma-Glutamyl Transpeptidase (product code JPZ). 2 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.

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Device
Colorimetric Method, Gamma-Glutamyl Transpeptidase
Product code
JPZ
Country
United States

Makers of Colorimetric Method, Gamma-Glutamyl Transpeptidase in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Cliniqa CorporationSan Marcos, CA, United StatesContract manufacturer, Manufacturer1September 9, 1992000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer, Manufacturer, Manufacturer for export1October 3, 1986000api.fda.gov
Abbott LaboratoriesIrving, TX, United StatesSpecification developer0000api.fda.gov
Alfa WassermannWest Caldwell, NJ, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer0000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Bialex LabWichita Falls, TX, United StatesManufacturer for export0000api.fda.gov
Medica Corp.Bedford, MA, United StatesManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov

Updated November 3, 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.