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Cordia CMV-M

by Cordis Corp.

510(k) K853889

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

Source FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK853889 Date21 Apr 1986ClearedStatusActive

Official records

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  • Withdrawn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
LKQ
Device class
Class II
Regulation
21 CFR Part 866.3175
Advisory committee
Microbiology
FDA decision
SESE Substantially Equivalent

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.

The Cordia CMV-M is an Antibody IgM/IgG Immunoassay Kit for Cytomegalovirus (CMV), designed to detect immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies in human serum or plasma. It is classified under product code LKQ and falls within the microbiology category, specifically for identifying CMV infections through serological testing.

This device is intended for in vitro diagnostic use in clinical microbiology laboratories. Supplied as a single-use kit, it requires no sterilisation beyond manufacturer-provided packaging. The kit is regulated under FDA 510(k) clearance (K853889), with a traditional review process completed in 1986. No MRI safety or reusable components are specified, and storage conditions align with standard immunoassay protocols.

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