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Orgentec Anti-Scl 70 Pin Immuno Assay

by Orgentec

510(k) K954814

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK954814 Date18 Apr 1996ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LJM
Device Class
Class II
Regulation
21 CFR Part 866.5100
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Orgentec Anti-Scl 70 Pin Immuno Assay is an in vitro diagnostic device classified as an antinuclear antibody (enzyme-labeled), antigen, and control. This assay is designed to detect antibodies against Scl-70, which is associated with systemic sclerosis, a connective tissue disorder.

The device is supplied as a single-use product and is intended for laboratory use. It is regulated under FDA 510(k) clearance with product code LJM and regulation number 866.5100, having been cleared on April 18, 1996. The device is Class II with special controls and is manufactured by Orgentec.

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Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the purpose of the Orgentec Anti-Scl 70 Pin Immuno Assay?

    The Orgentec Anti-Scl 70 Pin Immuno Assay is an in vitro diagnostic device designed to detect antibodies against Scl-70, which is associated with systemic sclerosis, a connective tissue disorder. It is intended for laboratory use only.

  • How is the Orgentec Anti-Scl 70 Pin Immuno Assay supplied?

    The device is supplied as a single-use product. It is not intended for reuse and should be handled according to laboratory protocols for single-use diagnostic devices to ensure accurate results and patient safety.

  • What is the regulatory status of the Orgentec Anti-Scl 70 Pin Immuno Assay?

    The device is regulated under FDA 510(k) clearance with product code LJM and regulation number 866.5100. It was cleared on April 18, 1996, and is classified as Class II with special controls.

  • What is the intended use of the Orgentec Anti-Scl 70 Pin Immuno Assay?

    This assay is specifically designed to detect antibodies against Scl-70, which is associated with systemic sclerosis. It is classified as an antinuclear antibody (enzyme-labeled), antigen, and control, and is intended for laboratory diagnostic purposes.