Varelisa Scl-70 Antibodies

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

510(k) Number

K944172 ↗

FDA Product Code

LJM

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Elias Ena Screen (Microtiter Plate)

  Class II

  FDA 510(k) K940622 Active Cleared 11 May 1994

• Varelisa Helicobacter Pylori Antibodies

  Class I

  FDA 510(k) K953873 Active Cleared 30 Aug 1996

• Varelisa Combined DNA Antibodies Eia

  Class II

  FDA 510(k) K944334 Active Cleared 17 Apr 1995

• Synelisa Tgab/Tmab

  Class II

  FDA 510(k) K915135 Active Cleared 8 Apr 1992

• Synelisa Cardiolipin Antibodies

  Class II

  FDA 510(k) K924421 Active Cleared 30 Nov 1992

• Syn Elisa Micro Albumin

  Class I

  FDA 510(k) K920216 Active Cleared 11 Mar 1992

See all devices from Elias U.S.A., Inc. →

• What is the VARELISA SCL-70 ANTIBODIES device used for?

  The VARELISA SCL-70 ANTIBODIES is an immunology device designed for laboratory use in detecting specific antibodies related to Scl-70. It functions as an antinuclear antibody (enzyme-labeled) antigen and controls.

• How is the VARELISA SCL-70 ANTIBODIES device supplied?

  The device is supplied by Elias U.S.A., Inc. The data does not specify whether it is single-use or reusable, nor does it provide information about sterility or storage conditions.

• What is the regulatory classification of the VARELISA SCL-70 ANTIBODIES device?

  The device is classified as Class 2 under product code LJM and received FDA 510(k) clearance on December 22, 1994, with K number K944172. It is not specified as having FDA clearance or CE marking in the provided data.

• What advisory committee reviewed the VARELISA SCL-70 ANTIBODIES device?

  The device was reviewed by the Immunology advisory committee (IM), which is an administrative field indicating how the submission was filed, not a clinical indication of the device's intended use.