Alastat Microplate Latex-Specific IgE Allergen

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

510(k) Number

K953014 ↗

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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• What is the Alastat Microplate Latex-Specific IgE Allergen used for?

  The Alastat Microplate Latex-Specific IgE Allergen is a diagnostic test system used to measure specific immunoglobulin E (IgE) antibodies in response to latex allergens in patient samples. It is designed for in vitro diagnostic applications in laboratory settings.

• How is the Alastat Microplate Latex-Specific IgE Allergen supplied?

  The device is supplied in a microplate format specifically designed for laboratory use. It is intended for in vitro diagnostic applications and is not indicated for single-use or reusable applications.

• What is the regulatory status of the Alastat Microplate Latex-Specific IgE Allergen?

  The device is regulated under FDA 510(k) clearance with the number K953014. It was classified as substantially equivalent and reviewed by the Immunology advisory committee.

• What is the purpose of measuring latex-specific IgE antibodies?

  Measuring latex-specific IgE antibodies helps identify allergic responses to latex in patients, which is important for diagnosing latex allergies and guiding appropriate patient care and avoidance strategies.