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Orgentec Anti-Cardiolipin Screen Elisa Assay

FDA 510(k)

Class II (US FDA 510(k))

510(k) K962926

by American Laboratory Products Co., Ltd.

Identifiers

510(k) Number
K962926 FDA 510(k)
FDA Product Code
MID FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5660 FDA 510(k)
Regulation Number
866.5660 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Orgentec Anti-Cardiolipin Screen Elisa Assay is an immunological test system designed for the detection of anticardiolipin antibodies. It functions as an in vitro diagnostic device used to identify specific immunological markers in patient samples.

This device is regulated under FDA 510(k) clearance number K962926. It is classified under regulation number 866.5660 within the immunology medical specialty.

Frequently asked questions

What is the primary purpose of the Orgentec Anti-Cardiolipin Screen ELISA Assay?

This device is an immunological test system designed to detect anticardiolipin antibodies in patient samples. It functions as an in vitro diagnostic tool to identify these specific immunological markers.

Is this device regulated by the FDA?

Yes, the Orgentec Anti-Cardiolipin Screen ELISA Assay is regulated under FDA 510(k) clearance number K962926. It is classified under regulation number 866.5660 within the immunology medical specialty.

What is the classification of this immunological test system?

The device is classified as a Class 2 medical device under the immunology specialty. It was cleared through the traditional 510(k) regulatory route, which determined it to be substantially equivalent to existing devices.

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: Orgentec Anti-cardiolipin Screen Elisa Assay, ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY - Innolitics, PDF K962926 Orgentec Anti-cardiolipin Screen Elisa Assay, ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY 510(k) K955449 - FDA.report, Anti-Cardiolipin IgG/IgM | ACR Klassifikations-Kriterium ... - ORGENTEC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
American Laboratory Products Co., Ltd.

Sources (1)

  • FDA 510(k) K962926 24 fields · synced Sep 22, 2026