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IGE Immuno Response Test Isotope Unit

by Immuno Nuclear Corp.

510(k) K863743

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK863743 Date15 Dec 1986ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Biotech's Ige Immuno Response Test Isotope Unit
510(k) Number
FDA Product Code
DHB
Device Class
Class II
Regulation
21 CFR Part 866.5750
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 IGE Immuno Response Test Isotope Unit is a System, Test, Radioallergosorbent (RAST) Immunological device designed for the in vitro measurement of immunoglobulin E (IgE) antibodies in serum or plasma. It employs radioisotope technology to detect allergen-specific IgE levels, aiding in the diagnosis and monitoring of allergic conditions such as asthma, hay fever, or food allergies.

This device is intended for laboratory use and is supplied as a Class II medical device with an FDA 510(k) clearance (K863743) under regulation 866.5750. It is intended for single-use and requires proper handling, storage, and disposal in compliance with radioactive material regulations. The unit operates under the advisory committee IM (Immunology) and is regulated as a diagnostic test system for immunological assessments.

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