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Diagnostic Reagents, Inc.

United StatesFDA applicant, unverified

Devices
65

What Diagnostic Reagents, Inc. makes

Diagnostic Reagents, Inc. produces calibrators, enzyme immunoassay (EIA) modifications, and urine controls for toxicology and drug testing, including calibrators for cannabinoids, methadone, cocaine metabolites, and theophylline, as well as EIA assays for amphetamines, methadone metabolites, phenytoin, and quinidine.

The company’s portfolio includes Class I, Class II, and unclassified devices, all listed via the FDA’s 510(k) pathway. These products are intended for laboratory use in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue65

Newest first, rows 51-65 of 65

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  • Phenytion Eia Test Ref K945725

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Phenobarbital Calibrators Ref K945316

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cannabinoid Eia Assay Ref K943998

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Acetaminophen Serum Tox Eia Assay Ref K961373

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Simul-Fer Serum Iron Test Kit Ref K820253

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Methadone Eia Assay Ref K972526

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Amphetamines Eia Test Ref K921554

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Theophylline Calibrators Ref K945338

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vancomycin Eia Assay Ref K983280

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tbg Diagnostic Kit Ref K820252

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ethyl Alcohol Assay Ref K923783

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • T3 Diagnostic Kit Ria Ref K821725

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Thyroxine Enzyme Immunoassay Ref K944703

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cannabinoid Urine Controls Ref K921141

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Thc Urine Calibrators Ref K920749

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 51-65 of 65

Showing 51-65 of 65