Cardiac T Elisa Troponin-T

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

510(k) Number

K924392 ↗

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 Cardiac T Elisa Troponin-T used for?

  The Cardiac T Elisa Troponin-T is used to measure troponin levels in the blood, which is an indicator of cardiac health.

• Is the Cardiac T Elisa Troponin-T a single-use device?

  The device description does not specify if it is single-use or reusable, but it is an immunoassay method, which is typically used in a laboratory setting.

• What is the regulatory classification of the Cardiac T Elisa Troponin-T?

  The device is classified as a Class II device with special controls, and its product code is MMI, regulated under the medical specialty description of Clinical Chemistry.

• Who is the manufacturer of the Cardiac T Elisa Troponin-T?

  The Cardiac T Elisa Troponin-T is manufactured by Boehringer Mannheim Corp.