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CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel

by Centers for Disease Control and Prevention 4 variants

510(k) K111507

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 NumberK111507 Date23 Aug 2011ClearedStatusActive

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  • Withdrawn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
OQW
Device Class
Class II
Regulation
21 CFR Part 866.3332
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel is a nucleic acid detection and identification device. It is designed to detect and identify influenza viruses, including the 2009 H1N1 influenza virus of swine origin.

This diagnostic panel has received FDA 510(k) clearance. It is categorized under the microbiology medical specialty and is intended for use in the detection and identification of influenza viruses.

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