Reaads Anti-Phosphatidylserine IgG/IgM Semi-Quantitative Test Kit

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

Full name

Modification to: Reaads Anti-Phosphatidylserine Igg/Igm Semi-Quantitative Test Kit

510(k) Number

K012567 ↗

FDA Product Code

MID

Device Class

Class II

Regulation

21 CFR Part 866.5660

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Reaads Igg Anti-B2GPI Test Kit

  Class II

  FDA 510(k) K982391 Active Cleared 7 Dec 1998

• Modification to Reaads Anti-Phosphatidylserine Iga Semi-Quantative Test Kit

  Class II

  FDA 510(k) K024195 Active Cleared 3 Jan 2003

• Reeads Anti-Phosphatidylserine Igg/Igm Semi-Quantitative Test Kit

  Class II

  FDA 510(k) K024196 Active Cleared 3 Jan 2003

• Reaads Igg Anti-Prothrombin Semi-Quantitative Test Kit

  Class II

  FDA 510(k) K001352 Active Cleared 9 Apr 2001

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

  Class II

  FDA 510(k) K022992 Active Cleared 25 Sep 2002

• Rhigene Hep-Ana Test System

  Class II

  FDA 510(k) K042680 Active Cleared 19 Nov 2004

See all devices from Corgenix, Inc. →

• What is the primary function of this test kit?

  The Reaads Anti-Phosphatidylserine IgG/IgM Semi-Quantitative Test Kit is an immunological test system designed to identify and measure the presence of IgG and IgM antibodies against phosphatidylserine.

• How is this device supplied for use?

  This device is supplied as a complete test kit intended for laboratory use. It functions as an anticardiolipin immunological test system to support clinical analysis.

• What is the regulatory status of this test kit?

  This device has received FDA 510(k) clearance under regulation number 866.5660. It is classified as an anticardiolipin immunological test system within the immunology medical specialty.