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Fibrinogen Calibrator Kit

by Dade Behring, Inc. 510(k)

Active United States

510(k) K072304

Overview

A fibrinogen calibrator kit is a device used to prepare reference curves for the assay of fibrinogen by the Clauss method. It is intended for use with Dade Behring Multifibrin U instrumentation.

The kit is supplied as a set of calibrators (levels 1 to 6) for in vitro diagnostic use. It is a Class II device cleared under FDA 510(k) K072304, with product code GFX, and is intended for use in clinical laboratory settings.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK072304 Date19 Sep 2007ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GFX
Device Class
Class II
Regulation
21 CFR Part 864.7340
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the fibrinogen calibrator kit used for?

    The fibrinogen calibrator kit is used to prepare reference curves for the assay of fibrinogen by the Clauss method, enabling accurate quantification of fibrinogen levels in plasma samples during in vitro diagnostic testing.

  • How is the fibrinogen calibrator kit supplied and what does it contain?

    The kit is supplied as a set of six calibrator levels (levels 1 to 6) designed for in vitro diagnostic use, providing a range of known fibrinogen concentrations to generate a calibration curve for assay accuracy.

  • Is the fibrinogen calibrator kit intended for single-use or reuse?

    The fibrinogen calibrator kit is intended for single-use in vitro diagnostic applications, as each calibrator level is used to establish a reference curve per assay run and is not designed for reprocessing or reuse after initial use.

  • What instrumentation is the fibrinogen calibrator kit compatible with?

    The fibrinogen calibrator kit is specifically intended for use with Dade Behring Multifibrin U instrumentation, ensuring compatibility and optimal performance when performing fibrinogen assays via the Clauss method on this platform.

  • Where should the fibrinogen calibrator kit be stored and used?

    The kit is intended for use in clinical laboratory settings and should be stored according to the manufacturer’s instructions, typically under refrigerated conditions as indicated for in vitro diagnostic reagents, to maintain stability and integrity of the calibrator levels.