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Reaads Igg Anti-B2GPI Test Kit

by Corgenix, Inc.

510(k) K982391

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 · Traditional NumberK982391 Date7 Dec 1998ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 27 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 IgG anti-B2GPI Test Kit is an enzyme-linked immunosorbent assay (ELISA) that utilizes a 96-microwell plate format. It is designed for the detection and semi-quantitation of IgG antibodies to Beta-2 Glycoprotein I in human serum or plasma.

The kit requires diluted serum samples, calibrator sera, and controls to be incubated in microwells coated with purified human Beta-2 Glycoprotein I. It is supplied as an in vitro diagnostic test system and has received FDA 510(k) clearance under product code MSV and regulation number 866.5660.

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Questions

AI-generated answers, 27 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 REAADS IgG anti-B2GPI Test Kit used for?

    The REAADS IgG anti-B2GPI Test Kit is designed for the detection and semi-quantitation of IgG antibodies to Beta-2 Glycoprotein I in human serum or plasma, using an enzyme-linked immunosorbent assay (ELISA) format to measure antibody levels associated with autoimmune conditions.

  • How is the REAADS IgG anti-B2GPI Test Kit supplied and what does it include?

    The kit is supplied as an in vitro diagnostic test system in a 96-microwell plate format and requires diluted serum samples, calibrator sera, and controls to be incubated in microwells coated with purified human Beta-2 Glycoprotein I for proper assay performance.

  • Is the REAADS IgG anti-B2GPI Test Kit intended for single-use or multiple uses?

    The REAADS IgG anti-B2GPI Test Kit is intended for single-use per test run, as it is an in vitro diagnostic system where reagents and microwells are consumed during the assay process and not designed for reuse after sample incubation and washing steps.