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Ventrex Coated Tube IGE Radioimmunoassay

by Ventrex Laboratories, Inc.

510(k) K905612

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 NumberK905612 Date21 Feb 1991ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
DGC
Device Class
Class II
Regulation
21 CFR Part 866.5510
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 Ventrex Coated Tube IGE Radioimmunoassay is a diagnostic device used for measuring immunoglobulin E (IgE) levels in serum or plasma samples. It employs radioimmunoassay technology, where coated tubes bind IgE antibodies, enabling precise quantification through radioactive detection methods.

This device is supplied as a single-use diagnostic kit and is regulated under FDA 510(k) clearance (K905612) with a classification of Class II (DGC product code). It is intended for use in clinical immunology laboratories, adhering to sterility standards for diagnostic reagents. Storage and handling follow standard radioisotope safety protocols.

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