Modification to Fidis Vasculitis, Model MX007

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

510(k) Number

K070458 ↗

FDA Product Code

MOB

Device Class

Class II

Regulation

21 CFR Part 866.5660

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Fidis Connective 10, Model MX006

  Class II

  FDA 510(k) K053653 Active Cleared 13 Mar 2006

• Fidistm Connective 10, Fidistm Analyzer, Caris

  Class II

  FDA 510(k) K102607 Active Cleared 3 Dec 2010

• Fidis Dsdna

  Class II

  FDA 510(k) K060380 Active Cleared 2 May 2006

• Fidis Tm Thyro, Model MX002

  Class II

  FDA 510(k) K061794 Active Cleared 21 Nov 2006

• Fidis Celiac

  Class II

  FDA 510(k) K053383 Active Cleared 29 Mar 2006

• Fidis Vasculitis, Model MX007

  Class II

  FDA 510(k) K053012 Active Cleared 2 Mar 2006

See all devices from Biomedical Diagnostics (Bmd) SA →

• What is the Modification to Fidis Vasculitis, Model MX007 used for?

  This test system is designed for detecting Antineutrophil Cytoplasmic Antibodies (ANCA) and is used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of various primary systemic small vessel vasculitis conditions.

• How is the Modification to Fidis Vasculitis, Model MX007 supplied?

  The device is supplied as part of the FIDIS system and is intended for use in laboratory settings. It is manufactured by Biomedical Diagnostics (BMD) SA and requires integration with their testing platform for proper functionality.

• What is the regulatory status of the Modification to Fidis Vasculitis, Model MX007?

  This device received FDA 510(k) clearance with K number K070458 on December 21, 2007. It is classified under product code MOB and regulation number 866.5660, with a medical specialty in Immunology, indicating it meets FDA safety and effectiveness requirements for its intended use.

• Is the Modification to Fidis Vasculitis, Model MX007 a single-use or reusable device?

  The device data does not specify whether this particular modification is single-use or reusable. As a test system component, it may be designed for either use pattern depending on the specific configuration of the FIDIS system it integrates with.