Immunodot Autoimmunity Screening Panel 2

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

510(k) Number

K900072 ↗

FDA Product Code

LJM

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• Immunwell Sjogren’s Syndrome B (La) Antibody Test

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• Immunodot Autoimmune Screening Panel 1

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• Immunowell Thyroglobulin Test

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• Immunodot Lyme Test

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  FDA 510(k) K894410 Active Cleared 30 Oct 1989

See all devices from General Biometrics, Inc. →

• What is the primary purpose of the Immunodot Autoimmunity Screening Panel 2?

  This device is designed for use in the field of immunology to assist clinicians in the detection of specific antibodies, specifically functioning as an antinuclear antibody enzyme-labeled antigen and control device.

• What is the regulatory status of this device?

  The Immunodot Autoimmunity Screening Panel 2 is classified as a Class 2 medical device under regulation number 866.5100 and has received FDA 510(k) clearance via the traditional pathway.

• Under which medical specialty is this device categorized?

  This device is categorized under the Immunology medical specialty, as it is utilized for the detection of antibodies and serves as an antinuclear antibody enzyme-labeled antigen and control system.