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VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator

by Steris

De Novo DEN230085

Active United States

De Novo

Valid until

No expiry

De Novo grant 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 De Novo, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN230085 Date12 Nov 2024DecidedStatusActive

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  • Withdrawn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 De Novo Active

Specification

De Novo

De Novo Number
FDA product code
SDC
Device class
Class II
Regulation
21 CFR Part 880.6930
Advisory committee
General Hospital
FDA decision
DENG De Novo granted

Overview

AI-generated summary, 21 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 VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator is a qualitative cleaning process protein indicator. It is designed to detect residual protein on surfaces after cleaning, serving as a tool to monitor the effectiveness of cleaning processes in healthcare environments.

This device is supplied for use in general hospital settings. It is a single-use indicator intended for monitoring cleaning efficacy, with no claims of sterility or reusability made in the provided data. The device is authorized under FDA 510(k) clearance (K number DEN230085) and is classified as a Class II medical device under regulation number 880.6930.

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Questions

AI-generated answers, 21 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 VERIFY RESI-TEST SLIDE-THRU CPP Indicator used for?

    It is used to detect residual protein on surfaces after cleaning, serving as a qualitative tool to monitor the effectiveness of cleaning processes in healthcare environments. This helps ensure surfaces are adequately cleaned by identifying protein residues that may indicate incomplete cleaning.

  • How is the VERIFY RESI-TEST SLIDE-THRU CPP Indicator supplied and is it reusable?

    The device is supplied for single-use only and is not intended for reuse. It is not sterile, as no sterility claims are made in the provided data. Each indicator is designed for one-time application to assess cleaning efficacy after a cleaning cycle.

  • What regulatory authorization does the VERIFY RESI-TEST SLIDE-THRU CPP Indicator have?

    The device is authorized under FDA 510(k) clearance with K number DEN230085. It is classified as a Class II medical device under regulation number 880.6930, with product code SDC, and was cleared following a direct review process.