Skip to content

QUANTEX IGA

by Instrumentation Laboratory CO

510(k) K962200

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 NumberK962200 Date25 Sep 1996ClearedStatusActive

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  • Withdrawn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
CZP
Device class
Class II
Regulation
21 CFR Part 866.5510
Advisory committee
Immunology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

QUANTEX IGA is a turbidimetric immunoassay for quantitative IgA determination in serum or plasma. It utilizes the ILab Clinical Chemistry System and includes anti-human IgA and buffer as part of a reagent kit.

The device is used in clinical laboratory settings by trained personnel to provide quantitative IgA concentration values, aiding clinicians in assessing protein metabolism and immune function. It is supplied as a reagent kit and has received FDA 510(k) clearance under product code CZP, classified as Class II with special controls.

Other devices from Instrumentation Laboratory Company

See all devices from Instrumentation Laboratory Company →

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the QUANTEX IGA used for?

    The QUANTEX IGA is used for quantitative determination of IgA in serum or plasma to aid clinicians in assessing protein metabolism and immune function, performed by trained personnel in clinical laboratory settings using the ILab Clinical Chemistry System.

  • How is the QUANTEX IGA supplied and what does it include?

    The QUANTEX IGA is supplied as a reagent kit that includes anti-human IgA and buffer, designed for use with the ILab Clinical Chemistry System to perform turbidimetric immunoassay measurements.

  • Is the QUANTEX IGA a single-use or reusable device?

    The QUANTEX IGA reagent kit is intended for single-use in clinical testing, as it contains consumable reagents (anti-human IgA and buffer) that are depleted during the assay process and not designed for reuse.