Dimension Vista Trf Flex Reagent Cartridge, Protein 1 Calibrator Protein 1 Control L, Control M, Control H

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K063322 ↗

FDA Product Code

DDG

Device Class

Class II

Regulation

21 CFR Part 866.5880

Advisory Committee

Immunology

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 Dimension Vista Trf Flex Reagent Cartridge used for?

  It is used as a transferrin antigen antiserum control to assess precision and bias in quantitative determinations during immunology testing on the Dimension Vista System, ensuring accurate calibration and quality control.

• How is the Dimension Vista Trf Flex Reagent Cartridge supplied?

  It is supplied as a liquid, ready-to-use reagent cartridge containing calibrator and Protein 1 controls at low, medium, and high levels for immediate use in calibration and quality control procedures.

• Is the Dimension Vista Trf Flex Reagent Cartridge for single use or reuse?

  The cartridge is intended for single use in vitro diagnostic procedures, as it contains ready-to-use liquid reagents that are consumed during calibration and quality control runs on the Dimension Vista System.