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REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit, Model 023-001

by Corgenix, Inc.

510(k) K022992

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 NumberK022992 Date25 Sep 2002ClearedStatusActive

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  • Withdrawn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
MID
Device Class
Class II
Regulation
21 CFR Part 866.5660
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) system designed for the immunological detection and semi-quantitative measurement of IgG and IgM anti-cardiolipin antibodies in human serum or plasma. This device falls under the category of immunological test systems, specifically for identifying markers associated with autoimmune conditions.

This test kit is intended for in vitro diagnostic use in clinical laboratory settings. It is supplied as a 96-well format for batch testing and requires no sterilisation beyond standard laboratory practices. The device is classified as Class II under FDA regulations and holds a 510(k) clearance, ensuring compliance with immunology diagnostic standards. Storage and handling follow standard in vitro diagnostic protocols.

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