Enzyme Immunoassay Anti-ssDNA Antibody Test

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

510(k) Number

K001900 ↗

FDA Product Code

LRM

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

  Class II

  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-SS-A/Ro Antibody Test Kit

  Class II

  FDA 510(k) K931495 Active Cleared 16 Jul 1993

See all devices from Helix Diagnostics, Inc. →

• What is the Enzyme Immunoassay Anti-ssDNA Antibody Test used for?

  The test is used to measure autoimmune antibodies in serum and body fluids to aid in detecting and evaluating autoimmune disorders, such as those that react with cellular nuclear constituents like deoxyribonucleic acid.

• How is the test supplied?

  The test is supplied as a reagent system for in vitro diagnostic use.

• Is the test single-use or reusable?

  The test is classified as a Class II device, and its reagent system is for in vitro diagnostic use, but the data does not specify if it is single-use or reusable.

• What is the regulatory classification of the test?

  The test is classified as a Class II device under regulation 866.5100 with product code LRM, and received traditional 510(k) clearance from the FDA.