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Fidis Vasculitis Assay Kit And Analyzer And Caris System

by Biomedical Diagnostics (Bmd) SA

510(k) K100917

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK100917 Date3 Nov 2010ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MOB
Device Class
Class II
Regulation
21 CFR Part 866.5660
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Fidis Vasculitis Assay Kit And Analyzer And Caris System is a test system used to detect the presence of anti-neutrophil cytoplasmic antibodies (ANCA). It is a semi-quantitative homogeneous fluorescent-based microparticle immunoassay using flow cytometry, designed to simultaneously detect the presence of ANCA directed against Myeloperoxidase (MPO), Serine Proteinase 3 (PR3) and antibodies directed against other targets.

The Fidis Vasculitis Assay Kit is intended for in vitro diagnostic use and is to be used on the Fidis Analyser, with the MLX-BOOSTER Software and Washer. It can also be used with the Caris system, a diluting and dispensing device. The device has been cleared under FDA 510(k) number K100917, with a device classification of Test System, Antineutrophil Cytoplasmic Antibodies (Anca).

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Fidis Vasculitis Assay Kit used for?

    The Fidis Vasculitis Assay Kit is used to detect the presence of anti-neutrophil cytoplasmic antibodies (ANCA) in vitro, specifically those directed against Myeloperoxidase (MPO), Serine Proteinase 3 (PR3), and other targets.

  • What devices are compatible with the Fidis Vasculitis Assay Kit?

    The Fidis Vasculitis Assay Kit is designed to be used with the Fidis Analyser, MLX-BOOSTER Software, Washer, and the Caris system, a diluting and dispensing device.

  • What is the regulatory status of the Fidis Vasculitis Assay Kit?

    The Fidis Vasculitis Assay Kit has been cleared under FDA 510(k) number K100917, classified as a Test System for Antineutrophil Cytoplasmic Antibodies (Anca).