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Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence Assay

by E.I. Dupont DE Nemours & Co., Inc.

510(k) K951851

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 NumberK951851 Date24 Jul 1996ClearedStatusActive

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  • Withdrawn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
LJO
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 Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence Assay is an in vitro diagnostic device classified as a cytomegalovirus antigen. It is designed to detect the presence of cytomegalovirus immediate early antigens using direct immunofluorescence techniques.

This device is regulated under FDA 510(k) clearance K951851 and is categorized as a Class II medical device. It is manufactured by E.I. Dupont DE Nemours and Co., Inc. and falls under the microbiology medical specialty.

Other devices from E.I. Dupont DE Nemours & Co., Inc.

See all devices from E.I. Dupont DE Nemours & Co., Inc. →

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 primary purpose of the Alliance Cytomegalovirus Assay?

    The Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence Assay is an in vitro diagnostic device used to detect the presence of cytomegalovirus immediate early antigens in clinical samples.

  • How does this assay detect cytomegalovirus antigens?

    This device utilizes direct immunofluorescence techniques to identify specific cytomegalovirus antigens within a laboratory setting.

  • What is the regulatory status of this device?

    The device is classified as a Class II medical device under the microbiology specialty and received FDA 510(k) clearance under the number K951851.