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Data / Medical devices / Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) / United States

FDA-registered makers of Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) in the United States: 20 establishments

20 establishments in the United States are registered with the FDA to make Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) (product code JIR). 6 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.

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Get makers of this device in the United StatesWatch these makers
Device
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Product code
JIR
Country
United States

Makers of Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Siemens Healthcare Diagnostics IncEast Walpole, MA, United StatesComplaint file establishment, Specification developer3November 24, 1999000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer3November 24, 1999030api.fda.gov
Siemens Healthcare Diagnostics, Inc.Mishawaka, IN, United StatesManufacturer2November 12, 1999000api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer2January 26, 2007000api.fda.gov
Acon Laboratories, Inc.San Diego, CA, United StatesManufacturer, Specification developer1April 30, 2015000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Repackager or relabeler1April 30, 2015000api.fda.gov
Aceso Laboratories Inc.Chino, CA, United StatesManufacturer0000api.fda.gov
Beckman Coulter, Inc.Chaska, MN, United StatesContract manufacturer0000api.fda.gov
Beckman Coulter, Inc.Miami, FL, United StatesSpecification developer0000api.fda.gov
BiomericaIrvine, CA, United StatesManufacturer for export0000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer0000api.fda.gov
E K Industries, Inc.Joliet, IL, United StatesManufacturer0000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer0000api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer0010api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesManufacturer for export0000api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
STS CorporationDuluth, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Sysmex America, Inc.Buffalo Grove, IL, United StatesContract manufacturer0000api.fda.gov
Sysmex America, Inc. - Vernon HillsVernon Hills, IL, United StatesContract manufacturer0000api.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.