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Cytomegalovirus (CMV) ELISA

by Virotech, Inc.

510(k) K904456

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK904456 Date3 Apr 1991ClearedStatusActive

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  • Withdrawn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 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LFZ
Device Class
Class II
Regulation
21 CFR Part 866.3175
Advisory Committee
Microbiology
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 Cytomegalovirus (CMV) ELISA is an enzyme‑linked immunoabsorbent assay designed to detect antibodies to human cytomegalovirus in clinical specimens. It is used in microbiology laboratories to assess serologic status for CMV infection.

The device is cleared under FDA 510(k) (K904456) as a Class II medical device, product code LFZ. It is supplied as a kit for in‑vitro diagnostic use, with the standard regulatory designation and manufacturer Virotech, Inc. No additional information on sterility, single‑use or reuse is provided in the source data.

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 Cytomegalovirus (CMV) ELISA used for?

    The Cytomegalovirus (CMV) ELISA is designed to detect antibodies to human cytomegalovirus in clinical specimens, used in microbiology laboratories to assess serologic status for CMV infection.

  • How is the Cytomegalovirus (CMV) ELISA supplied?

    The Cytomegalovirus (CMV) ELISA is supplied as a kit for in-vitro diagnostic use, as indicated in the device description.

  • What regulatory pathway was used for the Cytomegalovirus (CMV) ELISA?

    The Cytomegalovirus (CMV) ELISA was cleared under FDA 510(k) (K904456) as a Class II medical device with product code LFZ.