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Hoffmann-La Roche, Inc.

United StatesFDA applicant, unverified

Devices
50

What Hoffmann-La Roche, Inc. makes

The company produces in-vitro diagnostic reagents and test kits for clinical laboratory use, including radioimmunoassay kits for substances like human chorionic gonadotropin (HCG) and amphetamines, as well as reagents for measuring calcium, creatinine, lactate dehydrogenase (CPK-CS), and barbiturates. It also supplies standards for calibrating creatinine assays and slide-based diagnostic tests for drug detection.

These products are regulated under the FDA’s in-vitro diagnostic device categories, with most classified as Class I or Class II, while some fall under Class U (unclassified). They are authorised via 510(k) clearances or Premarket Approval Applications (PMA) and are listed in the FDA’s regulatory databases. The company is based in the United States.

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

Catalogue50

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  • Cobas Reagent For Calcium Ref K823577

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

  • Test, In-Vitro Diagnostic Ref K760089

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

  • Hcg Radioimmunoassay Ref K811116

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

  • Cobas Standards For Creatinine Ref K823572

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

  • Sensi-Tex Ref K790267

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

  • Abuscreen Radioimmunoassay - Amphetamine Ref K823212

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

  • Cpk-Cs Ref K790357

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

  • Cobas-Blo Reagents (Lactate Dehydro Ref K792658

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

  • Cobas Reagent For Creatinine Ref K823573

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

  • Abuscreen Radioimmunoassay-Amphetamine Ref K830482

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

  • Agglutex Barbiturates Test Kit Ref K812988

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

  • Sensi-Slide Ref K792657

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

  • Septi-Check Blood Culture Slide Ref K812731

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

  • Septi-Chek BH1 Blood Culture Bottle Ref K812732

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

  • Cobas-Bio Centrifugal Analyzer Ref K792671

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

  • Agglutex Morphine Test Kit Ref K812985

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

  • Isomune-Ck Ref K810905

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

  • Cobas Standards For Albumin Ref K823575

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

  • Roche B-Hcg Ria Ref K820613

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

  • Roche Hcg Standards Ref K801244

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

  • Enterotube Ii Ref K781236

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

  • Cobas Standard For Total Protein Ref K823576

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

  • Cobas Reagent For Inorganic Phosphorus Ref K823580

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

  • Abuscreen Radioimmunoassay For Cannabi Ref K820391

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

  • In Vitro Diagnostic Test Ref K770467

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

  • Human Plasma Control For Cea-Roche Ref K822219

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

  • Roche(R) B-Hcg Ria Urine Standard Ref K820942

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

  • Cobas Reagent For Albumin Ref K823574

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

  • Hcg Ria Pregnancy Test Ref K791206

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

  • Abuscreen Radioimmunoassay For Morphine Ref K830460

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

  • Abuscreen Radioummunoassay-Methaqualone Ref K830461

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

  • Roche Tsh Ria Ref K780428

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

  • Renak Ref K831694

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

  • Abuscreen Radioimmunoassay-Cocaine Meta Ref K830480

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

  • Septi-Chek Blood Culture Bottle Roche Ref K812729

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

  • Roche B-Hcg Standards Ref K820614

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

  • Agglutex Amphetamine Test Kit Ref K812986

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

  • Cobas Reagent For Total Protein Ref K823579

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

  • Agglutex Methaqualone Test Kit Ref K812987

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

  • Abuscreen Radioummunoassay--Urine Ref K830462

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

  • Abuscreen Ria For Phencyclidine Ref K790655

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

  • Cobas Standards For Calcium-In-Organic Ref K823578

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

  • Abuscreen Radioimmunoassay-Phencyclidine Ref K830481

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

  • T3 Ria Ref K771623

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

  • Amylochrome Stat Separator, Test Ref K790485

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

  • Septi-Chek Columbia Broth Blood Culture Ref K812730

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

  • Abuscreen Radioimmunoassay-Barbiturate Ref K830479

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

  • Bhcg-Roche Eia Ref K850727

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

  • Roche Immunochemical Ld Isoenzy Reagents Ref K791373

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

  • Cea-Roche Test Kit Ref P800063

    Active Regimes: PMA Registry: PMA Class:II

Rows 1-50 of 50

Frequently asked questions

How many devices does Hoffmann-La Roche, Inc. have in the registry?

The registry currently lists 50 devices for Hoffmann-La Roche, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Hoffmann-La Roche, Inc.'s devices?

Among its 50 most recently registered devices, Hoffmann-La Roche, Inc. has devices listed in FDA 510(k) (49 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Hoffmann-La Roche, Inc.'s devices fall under?

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

What are the newest devices from Hoffmann-La Roche, Inc. in the registry?

The most recently registered devices listed for Hoffmann-La Roche, Inc. include COBAS REAGENT FOR CALCIUM, TEST, IN-VITRO DIAGNOSTIC, HCG RADIOIMMUNOASSAY and COBAS STANDARDS FOR CREATININE.

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