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Quantimetrix Quan Test-Red Protein Assay System

by Quantitative Medicine, Inc.

510(k) K904603

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK904603 Date25 Jan 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
CEK
Device Class
Class II
Regulation
21 CFR Part 862.1635
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 Quantimetrix Quan Test-Red Protein Assay System is a colorimetric device used for the quantitative determination of total protein in cerebrospinal fluid and urine. It utilizes a pyrogallol red molybdate dye-binding method to measure protein levels in microliter samples.

This system is designed for use in both manual and automated laboratory settings. The reagents are stable until their expiration date when stored according to manufacturer instructions. This device has received FDA 510(k) clearance under K904603.

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Questions

AI-generated answers, 6 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 Quantimetrix Quan Test-Red Protein Assay System used for?

    The Quantimetrix Quan Test-Red Protein Assay System is a colorimetric diagnostic tool used for the quantitative determination of total protein levels in cerebrospinal fluid and urine samples.

  • How does the assay system measure protein levels?

    This system utilizes a pyrogallol red molybdate dye-binding method to measure protein concentrations within microliter-sized samples.

  • Can this system be used in automated laboratory settings?

    The system is designed for versatility and can be utilized in both manual and automated laboratory settings to accommodate different clinical workflows.

  • How should the reagents be stored to ensure stability?

    The reagents are stable until their specified expiration date, provided they are stored in accordance with the manufacturer's instructions.

  • What is the regulatory status of this device?

    This device has received FDA 510(k) clearance under K904603, which indicates it has been determined to be substantially equivalent to a predicate device.