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Aeskulisa ENA 6 S

FDA 510(k)

Class II (US FDA 510(k))

510(k) K041753

by Aesku Diagnostics

Identifiers

510(k) Number
K041753 FDA 510(k)
FDA Product Code
LLL 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 Aeskulisa ENA 6 S is an extractable antinuclear antibody, antigen, and control kit classified as a solid-phase enzyme immunoassay. It is designed for the qualitative detection of IgG antibodies against six cellular and nuclear antigens in human serum, aiding in autoimmune serology diagnostics.

This device is intended for in vitro diagnostic use in clinical laboratories. Supplied as a kit, it is intended for single-use and requires no special handling beyond standard laboratory procedures. The device is FDA-cleared under 510(k) K041753 and falls under regulation 866.5100, with a classification of Class II. Sterility and storage conditions are not specified but must comply with standard in vitro diagnostic device requirements.

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: AESKULISA ENA-6S - w.aesku.com, AESKULISA® ELISA Test Kits - AESKU We take care of your health, Instruction Manual - aj-ebiochip.angio-lab.aesku.com, AESKULISA ENA-6S - w.aesku.com, AESKULISA ENA 6 S (K041753) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Aesku Diagnostics

Sources (1)

  • FDA 510(k) K041753 24 fields · synced Oct 6, 2026