DIMERTEST

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

510(k) Number

K080069 ↗

FDA Product Code

DAP

Device Class

Class II

Regulation

21 CFR Part 864.7320

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from American Diagnostica, Inc. →

• What clinical purpose does the DIMERTEST serve?

  The DIMERTEST measures D‑Dimer, a fibrinogen and fibrin split product antigen, providing quantitative data that helps clinicians evaluate disorders of fibrinolysis, hemostasis and thrombosis, such as suspected pulmonary embolism or deep‑vein thrombosis.

• How is the DIMERTEST supplied and intended for use?

  It is supplied as a single‑use device, meaning each test kit is used once and then discarded. This eliminates cross‑contamination risk and ensures consistent assay performance for each patient sample.

• Is the DIMERTEST compatible with MRI environments?

  No, the DIMERTEST is not MRI safe. It should be stored and used away from magnetic resonance imaging equipment to avoid any potential interference or safety hazards.

• What regulatory clearance does the DIMERTEST have?

  The device has FDA 510(k) clearance under product code DAP, indicating it is substantially equivalent to a legally marketed predicate device and cleared for clinical use in the United States.