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Immuno Assay Corp.

United StatesFDA applicant, unverified

Devices
10

What Immuno Assay Corp. makes

Immuno Assay Corp. manufactures diagnostic radioimmunoassay (RIA) kits for measuring thyroid hormones (T3, TSH, T4), digoxin levels, cortisol, thyroid-binding globulin (TBG), and iron metabolism markers (via the COMBO-FER diagnostic). Their portfolio includes coated-tube formats (RIACOAT) and combined assay systems for clinical laboratory testing.

The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I (general controls) or Class II (special controls). These assays are intended for in vitro diagnostic use and are listed in the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue10

Newest first, rows 1-10 of 10

  • T4 Ria Kit Ref K810811

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

  • T3 (Ria) Kit Ref K811213

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

  • Tsh (Ria) Kit Ref K820089

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

  • Riacoat T-4 Ref K833745

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

  • Digoxin (Ria) Kit Ref K811212

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

  • Tbg Diagnostic Kit Ref K811725

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

  • Combo-Fer Iron Diagnostic Ref K811954

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

  • Cortisol (Ria) Kit Ref K820074

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

  • Ria Coat Digoxin Ref K833842

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

  • T3 Uptake Kit Ref K810857

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

Frequently asked questions

How many devices does Immuno Assay Corp. have in the registry?

The registry currently lists 10 devices for Immuno Assay Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Immuno Assay Corp.'s devices?

Among its 10 most recently registered devices, Immuno Assay Corp. has devices listed in FDA 510(k) (10 devices).

What risk classes do Immuno Assay Corp.'s devices fall under?

Among its 10 most recently registered devices, the classes recorded for Immuno Assay Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Immuno Assay Corp. in the registry?

The most recently registered devices listed for Immuno Assay Corp. include T4 RIA KIT, T3 (RIA) KIT, TSH (RIA) KIT and RIACOAT T-4.

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