Varelisa Gliadin Iga Antibodies Model #19848/19896

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K041354 ↗

FDA Product Code

MST

Device Class

Class II

Regulation

21 CFR Part 866.5750

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K050625 Active Cleared 26 Apr 2005

• Varelisa Gliadin Igg Antibodies

  Class II

  FDA 510(k) K041357 Active Cleared 2 Aug 2004

• Celikey Igg Itg Igg Antibodies, Model 17996

  Class II

  FDA 510(k) K041173 Active Cleared 2 Aug 2004

• Celikey Ttg (Human, Recombinant) Iga Antibodies Model #18148/18196

  Class II

  FDA 510(k) K041174 Active Cleared 19 Jul 2004

• Varelisa Recombi Ctd Screen, Model 13096

  Class II

  FDA 510(k) K050967 Active Cleared 28 Jun 2005

• Varelisa Mpo Anca, Model 17648/17696

  Class II

  FDA 510(k) K041040 Active Cleared 16 Jun 2004

See all devices from Sweden Diagnostics (Germany) GmbH →

• What is the Varelisa Gliadin Iga Antibodies device used for?

  The Varelisa Gliadin Iga Antibodies are used to aid in the diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis by determining gliadin IgA antibodies in serum or plasma.

• What is the regulatory classification of the Varelisa Gliadin Iga Antibodies?

  The device is classified as a Class 2 Immunology device with product code MST and is regulated under regulation number 866.5750.

• What is the clearance type for the Varelisa Gliadin Iga Antibodies Model #19848/19896?

  The device has FDA 510K clearance, which is a Traditional clearance type.

• Who is the manufacturer of the Varelisa Gliadin Iga Antibodies Model #19848/19896?

  The device is supplied by Sweden Diagnostics (Germany) GmbH.