Turbo-Rast Specific IgE Assay

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

510(k) Number

K904330 ↗

FDA Product Code

DHB

Device Class

Class II

Regulation

21 CFR Part 866.5750

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Ventrex Laboratories, Inc. →

• What is the Turbo-Rast Specific IgE Assay used for?

  The Turbo-Rast Specific IgE Assay is used to detect specific immunoglobulin E (IgE) antibodies in patient samples as part of allergy diagnostics. It performs radioallergosorbent (Rast) immunological testing to identify allergen-specific IgE, aiding in the clinical evaluation of allergic conditions.

• How is the Turbo-Rast Specific IgE Assay supplied and intended for use?

  The device is supplied as a complete test system and is intended for use in immunology laboratory settings. It is designed for professional laboratory personnel to perform specific IgE testing on patient specimens as part of in vitro allergy diagnostic workflows.

• What regulatory pathway was used for the Turbo-Rast Specific IgE Assay?

  The Turbo-Rast Specific IgE Assay received FDA 510(k) clearance under submission number K904330, with a traditional clearance type and a substantially equivalent decision. It is classified as a Class II medical device under product code DHB and regulation number 866.5750.