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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

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  • T4 Diagnostic Kit Ref K820251

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

  • Serum Tox Calibrator Ref K961372

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

  • Methadone Enzyme Immunoassay Ref K934667

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

  • Cannabinoid Urine Controls Ref K932113

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

  • Amphetamines Eia Assay Modification Ref K934891

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

  • Thc Urine Calibrators Ref K923386

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

  • Urine A Calibrator Ref K920208

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

  • Cocaine Metabolite Eia Test Ref K960187

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

  • Theophylline Enzyme Immunoassay Ref K952596

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

  • Methadone Metabolite Eia Assay Ref K931780

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

  • Tricyclics Serum Tox Assay Ref K961393

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

  • Phenytoin Calibrators Ref K945337

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

  • Quinidine Enzyme Immunoassay Ref K964212

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

  • Barbiturate Serum Tox Eia Assay Ref K960664

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

  • Opiate Eia Assay Ref K915180

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

  • T-Uptake Calibrators Ref K951585

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

  • Procainamide Enzyme Immunoassay Ref K962463

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

  • Cocaine Metabolite Eia Assay Modification Ref K935016

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

  • Primidone Eia Test Ref K960526

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

  • Phencyclidine Eia Assay Ref K935320

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

  • Barbiturate Eia Essay (Modification) Ref K955928

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

  • T-Uptake Eia Test Ref K951586

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

  • Modification Of Tricyclic Serum Tox Eia Assay Ref K983268

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

  • Methaqualone Enzyme Immunoassay Ref K940123

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

  • Ethyl Alcohol Calibrators & Control Ref K924733

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

  • Urine Calibrator And Control Ref K931506

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

  • Carbamazepine Eia Test Ref K955100

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

  • Phencyclidine Eia Assay Ref K915179

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

  • 50NG/Ml Cocaine Metabolite Calibrator Ref K972835

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

  • T3 Uptake Diagnostic Kit Ref K821722

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

  • Napa Eia Assay Ref K983812

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

  • Valproic Acid Eia Test Ref K961988

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

  • Aed Calibrators Ref K961273

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

  • Digoxin Immunoassay Ref K983323

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

  • Lidocaine Eia Assay Ref K973102

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

  • Salicylate Assay Ref K961131

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

  • Benzodiazepine Enzyme Immunoassay Ref K930529

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

  • Barbiturate Eia Test Ref K925491

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

  • Urine Calibrator Ref K940935

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

  • Drugs Of Abuse Urine Calibrators And Controls Ref K983159

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

  • Phenobarbital Enzyme Immunoassay Ref K946210

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

  • Urine Calibrators And Controls Modification Ref K935101

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

  • Propoxphene Eia Test Ref K943414

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

  • Cocaine Metabolite Eia Test Ref K915371

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

  • Drug Of Abuse Urine Control Ref K920477

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

  • Phencyclidine Eia Assay, Modification Ref K920957

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

  • Cannabinoid Eia Test Ref K920311

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

  • Digoxin Enzyme Immunoassay Ref K963835

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

  • Benzodiazepine Serum Tox Eia Test Ref K960708

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

  • Ph-Detect Test Ref K952178

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

Rows 1-50 of 65

Showing 1-50 of 65

Frequently asked questions

How many devices does Diagnostic Reagents, Inc. have in the registry?

The registry currently lists 65 devices for Diagnostic Reagents, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Diagnostic Reagents, Inc.'s devices?

Among its 50 most recently registered devices, Diagnostic Reagents, Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Diagnostic Reagents, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Diagnostic Reagents, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Diagnostic Reagents, Inc. in the registry?

The most recently registered devices listed for Diagnostic Reagents, Inc. include T4 DIAGNOSTIC KIT, SERUM TOX CALIBRATOR, METHADONE ENZYME IMMUNOASSAY and CANNABINOID URINE CONTROLS.

Generated automatically from registry data and not verified by a human reviewer.