Dia Fibrin

510(k) Number

K841366 ↗

FDA Product Code

KQJ

Device Class

Class II

Regulation

21 CFR Part 864.7340

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Heparin Coagulation Control Plasma 1-

  Class II

  FDA 510(k) K841462 Active Cleared 1 Jun 1984

• Dia Reptin

  Class I

  FDA 510(k) K841365 Active Cleared 1 Jun 1984

• Calcium Chloride

  Class II

  FDA 510(k) K841522 Active Cleared 30 Apr 1984

• Fibrinogen Test

  Class II

  FDA 510(k) K834571 Active Cleared 4 Feb 1984

• Diatimer-1 Blood Plasma Clot Timing Instrument

  Class II

  FDA 510(k) K854089 Active Cleared 6 Jan 1986

• Diacelin

  Class II

  FDA 510(k) K840288 Active Cleared 23 Apr 1984

See all devices from Diatech, Inc. →

• What is the Dia Fibrin system used for?

  The Dia Fibrin system is designed for in vitro diagnostic use to measure fibrinogen levels in blood samples. Fibrinogen is a critical protein in blood clotting, and accurate measurement helps diagnose and manage coagulation disorders such as hemophilia or disseminated intravascular coagulation (DIC). It is specifically intended for clinical laboratory settings to support hematological assessments.

• How is the Dia Fibrin system supplied, and is it reusable?

  The Dia Fibrin system is supplied as a single-use reagent kit. Each kit is pre-packaged and does not require additional sterilization beyond the manufacturer’s provided packaging. This ensures consistency and safety for each use, eliminating the need for reprocessing or reuse.

• Does the Dia Fibrin system require special storage conditions?

  Yes, the Dia Fibrin system must be stored under controlled conditions as specified by the manufacturer. Proper storage ensures the stability and accuracy of the reagent kit, which is essential for reliable fibrinogen measurements in clinical diagnostics.

• Can the Dia Fibrin system be used in an MRI environment?

  No, the Dia Fibrin system is not designed for use in MRI environments. The device is intended solely for in vitro diagnostic use in clinical laboratories, where it operates independently of magnetic fields or imaging equipment.

• What regulatory clearance does the Dia Fibrin system hold?

  The Dia Fibrin system holds FDA 510K clearance under the reference number K841366. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device and complies with regulatory standards outlined in 21 CFR 864.7340 for hematology diagnostic devices.