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Data / Medical devices / Biuret (Colorimetric), Total Protein / United States

FDA-registered makers of Biuret (Colorimetric), Total Protein in the United States: 20 establishments

20 establishments in the United States are registered with the FDA to make Biuret (Colorimetric), Total Protein (product code CEK). 8 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Device
Biuret (Colorimetric), Total Protein
Product code
CEK
Country
United States

Makers of Biuret (Colorimetric), Total Protein in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Beckman Coulter, Inc.Brea, CA, United StatesManufacturer, Specification developer2November 23, 1992000api.fda.gov
Quantimetrix Corp.Redondo Beach, CA, United StatesManufacturer2January 25, 1991000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer2August 11, 1995000api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer2October 24, 1996000api.fda.gov
Carolina Liquid ChemistriesBrea, CA, United StatesManufacturer1March 12, 1996000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer, Manufacturer1August 19, 1987000api.fda.gov
Horiba Instruments IncorporatedCanton, MI, United StatesManufacturer1September 14, 1982000api.fda.gov
Infrared Laboratory Systems dba SYNERMEDWestfield, IN, United StatesManufacturer1September 7, 1990000api.fda.gov
Abaxis, Inc.Union City, CA, United StatesManufacturer0000api.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.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Bialex LabWichita Falls, TX, United StatesManufacturer, Manufacturer for export0000api.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 developer0020api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer0000api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer0040api.fda.gov

Updated November 2, 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.