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VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators

by Ortho-Clinical Diagnostics, Inc.

De Novo DEN210040

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA De Novo, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN210040 Date5 May 2023DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 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  • Withdrawn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
QVP
Device Class
Class II
Regulation
21 CFR Part 866.3983
Advisory Committee
Microbiology
FDA Decision
DENG De Novo granted

Overview

AI-generated summary, 19 Sep 2026

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

This device is a chemiluminescent immunoassay for the qualitative detection of total antibodies to SARS-CoV-2. It is classified as a SARS-CoV-2 serology test under the device nomenclature for microbiology diagnostics, designed to identify antibodies in human serum and plasma samples collected via K₂-EDTA, K₃-EDTA, or lithium heparin.

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators are intended for use exclusively on the VITROS ECi/ECiQ/3600 Immunodiagnostic System or the VITROS 5600/XT 7600 Integrated Systems. Supplied as single-use components, the device requires no sterilisation beyond manufacturer-provided packaging. Regulated under FDA 510(k) clearance (K210040), it is distributed for in vitro diagnostic use in clinical microbiology settings.

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