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Dimension Diagnostics

Country not established

Devices
8

What Dimension Diagnostics makes

Dimension Diagnostics produces laboratory assay controls and reagents for clinical diagnostics, including serum fraction (SF) controls, immunoassay controls, and specialized tests for urology and chemistry parameters. Products like CRITIC-SF and UROL-QUAL are designed to monitor assay performance, while ALT-30, 60, and 100 serve as liquid controls for liver function testing. Immunoassay controls such as IMA-TROL and CRITIC-ARS support precision in hormone and analyte measurements, and DIMENSION-WBG targets whole-blood glucose monitoring.

The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the 510(k) clearance pathway. Products are intended for use in clinical laboratories and diagnostic settings, adhering to US regulatory standards. The manufacturer is based in the United States.

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

Catalogue8

Newest first, rows 1-8 of 8

  • Critic - Sf, Assayed Ref K854967

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

  • Urol-Qual Ref K844760

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

  • Alt-30, 60 And 100 Ref K861366

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

  • Ima-Trol Immunoassay Control Ref K844848

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

  • Critic-Ars Ref K844709

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

  • Critic C Level I & Ii Ref K853943

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

  • Dimension-Wbg Ref K863223

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

  • Urol-Guant Ref K852295

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

Frequently asked questions

How many devices does Dimension Diagnostics have in the registry?

The registry currently lists 8 devices for Dimension Diagnostics. Devices recorded under merged duplicate company entries are counted once.

Which registries list Dimension Diagnostics's devices?

Among its 8 most recently registered devices, Dimension Diagnostics has devices listed in FDA 510(k) (8 devices).

What risk classes do Dimension Diagnostics's devices fall under?

Among its 8 most recently registered devices, the classes recorded for Dimension Diagnostics's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Dimension Diagnostics in the registry?

The most recently registered devices listed for Dimension Diagnostics include CRITIC - SF, ASSAYED, UROL-QUAL, ALT-30, 60 AND 100 and IMA-TROL IMMUNOASSAY CONTROL.

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