Ana Test Kit

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

510(k) Number

K811022 ↗

FDA Product Code

DHN

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Immuno-Diagnostic Products, Inc. →

• What is the ANA TEST KIT used for?

  The ANA TEST KIT is an Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control device used in immunology testing to detect antinuclear antibodies in patient samples.

• How is the ANA TEST KIT supplied?

  The ANA TEST KIT is supplied with a product code of DHN and regulation number 866.5100, manufactured by Immuno-Diagnostic Products, Inc.

• What is the regulatory status of the ANA TEST KIT?

  The ANA TEST KIT has FDA 510K clearance with a decision description of Substantially Equivalent, classified as a class 2 device under medical specialty of Immunology.

• Is the ANA TEST KIT single-use or reusable?

  The device data does not specify whether the ANA TEST KIT is single-use or reusable, only that it is classified as a class 2 device for immunology testing.