Antinuclear Antibody Immunological

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K833984 ↗

FDA Product Code

KTL

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• What is the Antinuclear Antibody Immunological device used for?

  This device is used in immunology testing for the detection of antinuclear antibodies, which helps in the diagnosis of autoimmune diseases by identifying antibodies that target components within the cell nucleus.

• How is the Antinuclear Antibody Immunological device supplied?

  The device is supplied as a Class II medical device with FDA 510K clearance under product code KTL, manufactured by Intl. Diagnostic Technology, and is intended for laboratory use.

• Is the Antinuclear Antibody Immunological device single-use or reusable?

  The device data does not specify whether it is single-use or reusable, indicating that this information is not provided in the available documentation.

• What regulatory status does the Antinuclear Antibody Immunological device have?

  The device has FDA 510K clearance with a decision code of SESE, indicating it is substantially equivalent to other devices already on the market, and is classified under product code KTL.