Dimension Vista Flex Reagent Cartridges / Kit Assays

No FDA recalls found in the data synced 6 Oct 2026.

Full name

The Dimension Vista Flex Reagent Cartridges / Kit Assays

510(k) Number

K062128 ↗

FDA Product Code

JHS

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K981622 Active Cleared 8 Jun 1998

• Stratus Cs Acute Care Troponin I Testpak, Model Cctni

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• Tgl Flex Reagent Cartridge

  Class I

  FDA 510(k) K010871 Active Cleared 9 Jul 2001

See all devices from Dade Behring, Inc. →

• What is the intended use of the Dimension Vista Flex Reagent Cartridges?

  The cartridges are for use on the Dimension Vista system to perform various clinical chemistry and therapeutic drug monitoring assays, utilizing a Differential Rate Kinetic Method.

• Are the reagent cartridges supplied sterile?

  The description does not explicitly state the sterility of the cartridges, but they are prepackaged for use on a clinical chemistry analyzer, implying they are designed for single-use and handled in a sterile or controlled environment.

• What regulatory authorization does the device have?

  The Dimension Vista Flex Reagent Cartridges / Kit Assays have an FDA 510K authorization, classified as a Class II device with special controls.