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Quantimetric Plus IGA Reagent Kit

by Kallestad Laboratories, Inc.

510(k) K855009

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 NumberK855009 Date26 Feb 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  • Withdrawn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)

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, 1 Oct 2026

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

The Quantimetric Plus IGA Reagent Kit is an in vitro diagnostic device used for the quantitative measurement of Immunoglobulin A (IgA) in human serum or plasma. It employs immunoturbidimetric assay technology to detect and quantify IgA levels, aiding in the diagnosis and monitoring of immune-related conditions.

This kit is supplied as a reagent set for laboratory use and is intended for single-use per manufacturer specifications. It is classified as a Class II device under FDA regulations (21 CFR 866.5510) and has received FDA 510(k) clearance (K855009). The kit includes antigen, antiserum, and control components, with registration numbers and product codes listed for regulatory tracking. Storage and handling follow standard laboratory protocols for immunodiagnostic reagents.

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Questions

AI-generated answers, 1 Oct 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 Quantimetric Plus IGA Reagent Kit used for?

    The Quantimetric Plus IGA Reagent Kit is an in vitro diagnostic device used for the quantitative measurement of Immunoglobulin A (IgA) in human serum or plasma, aiding in the diagnosis and monitoring of immune-related conditions.

  • How is the Quantimetric Plus IGA Reagent Kit supplied?

    The kit is supplied as a reagent set for laboratory use and includes antigen, antiserum, and control components. It is intended for single-use per manufacturer specifications.

  • What is the regulatory classification of this device?

    The Quantimetric Plus IGA Reagent Kit is classified as a Class II device under FDA regulations (21 CFR 866.5510) and has received FDA 510(k) clearance (K855009).

  • What technology does this reagent kit employ?

    The kit employs immunoturbidimetric assay technology to detect and quantify IgA levels in human serum or plasma samples.