Enzyme Immunoassay Anti-SS-A/Ro Antibody Test Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K931495 ↗

FDA Product Code

LLL

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Enzyme Immunoassay Anti-Double Stranded DNA (Dsdna) Test Kit

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  FDA 510(k) K960091 Active Cleared 20 Mar 1996

• Enzyme Immunoassay Anti-Sci-70 Antibody Test Kit

  Class II

  FDA 510(k) K951798 Active Cleared 17 Jul 1995

• Diamedix Immunosimplicity Ana (Is-Ana) Screen Test System

  Class II

  FDA 510(k) K980337 Active Cleared 12 May 1998

• Anti-Ss-B/La Antibody Test

  Class II

  FDA 510(k) K932419 Active Cleared 5 Aug 1993

• Anti-Dsdna Antibody Test

  Class II

  FDA 510(k) K913041 Active Cleared 5 Nov 1991

• Enzyme Immunoassay Anti-Sm Antibody Test Kit

  Class II

  FDA 510(k) K940510 Active Cleared 20 Apr 1994

See all devices from Helix Diagnostics, Inc. →

• What is the purpose of the Anti-SS-A/Ro Antibody Test Kit?

  This device is used to qualitatively and quantitatively determine the presence of IgG antibodies against the SS-A/Ro antigen complex in human serum or plasma. The SS-A/Ro complex consists of two proteins, Ro52 and Ro60, and this test helps identify antibodies directed against these proteins.

• How is the test kit supplied and is it reusable?

  The device is supplied as a kit and is intended for use in a laboratory setting. It is a single-use device and is not reusable.

• Is the device sterile and how should it be stored?

  The device is not sterile and must be stored according to the manufacturer's instructions.

• What is the regulatory status of this device?

  The Enzyme Immunoassay Anti-SS-A/Ro Antibody Test Kit has received FDA 510(k) clearance (K931495) from Helix Diagnostics, Inc. for use in the United States.