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Total Protein Reagent

by Sigma Chemical Co.

510(k) K890278

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 NumberK890278 Date9 Mar 1989ClearedStatusActive

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  • Withdrawn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 Total Protein Reagent is a biuret-based reagent used for the colorimetric determination of total protein concentration in solution. Copper ions in the alkaline reagent react with peptide bonds in proteins, resulting in a purple color with an absorbance maximum of 540 nm. This reagent provides a simple, rapid, and highly sensitive method for protein quantification.

The Total Protein Reagent is supplied in various sizes including T1 ML and 500ML formats. It is intended for use in clinical chemistry applications and is classified as a Class II medical device. The device has received FDA 510(k) clearance with K number K890278 and is regulated under product code CEK.

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