Boehringer Mannheim Cardiac T Troponin T

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

Full name

Boehringer Mannheim Cardiac T Tropnin T

510(k) Number

K955868 ↗

FDA Product Code

MMI

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Boehringer Mannheim Corp. →

• What is the Boehringer Mannheim Cardiac T Troponin T device used for?

  This device is an immunoassay method designed to measure cardiac troponin T levels in blood samples, serving as a diagnostic tool in clinical chemistry to aid in the assessment of cardiac injury.

• How is the Boehringer Mannheim Cardiac T Troponin T supplied and intended for use?

  It is supplied as a reagent system for in vitro diagnostic use and is intended for use in clinical laboratory settings to quantitatively measure troponin T in blood specimens.

• Is the Boehringer Mannheim Cardiac T Troponin T described as sterile, single-use, or reusable?

  The provided data does not describe this device as sterile, single-use, or reusable; it is characterized solely as a reagent system for in vitro diagnostic use in clinical laboratories.