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Test, (Ivdp) Antinuclear Antibody

FDA 510(k)

Class II (US FDA 510(k))

510(k) K760153

by Zeus Scientific, Inc.

Identifiers

510(k) Number
K760153 FDA 510(k)
FDA Product Code
DHN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5100 FDA 510(k)
Regulation Number
866.5100 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Test, (Ivdp) Antinuclear Antibody is an immunological test system designed to measure autoimmune antibodies in serum, body fluids, and tissues. It utilizes immunochemical techniques to detect antibodies that react with cellular nuclear constituents, such as ribonucleic acid and deoxyribonucleic acid.

This device is manufactured by Zeus Scientific, Inc. and has received FDA 510(k) clearance under K760153. It is classified as a class 2 medical device under regulation number 866.5100 within the immunology specialty.

Frequently asked questions

What is the primary purpose of the Test, (IVDP) Antinuclear Antibody?

This device is an immunological test system designed to detect and measure autoimmune antibodies that react with cellular nuclear constituents, including ribonucleic acid and deoxyribonucleic acid, within serum, body fluids, and tissues.

What is the regulatory status of this device?

The device has received FDA 510(k) clearance under submission number K760153. It is classified as a class 2 medical device under regulation number 866.5100 within the immunology specialty.

Who is the manufacturer of this test system?

The Test, (IVDP) Antinuclear Antibody is manufactured by Zeus Scientific, Inc., located in McHenry, Illinois.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TEST, (IVDP) ANTINUCLEAR ANTIBODY (K760153) — FDA 510(k) | Innolitics, PDF K760153 - Test, (Ivdp) Antinuclear Antibody, ANA Screen Test System - ZEUS Scientific

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Zeus Scientific, Inc.

Sources (1)

  • FDA 510(k) K760153 24 fields · synced Sep 24, 2026