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Verigene Enteric Pathogen Nucleic Acid Test (Ep)

by Nanospere, Inc.

510(k) K142033

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK142033 Date10 Oct 2014ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2952-2018 FDA Class II initiated 8 May 2018

    Elevated false positive results Yersinia enterocolitica (Yersinia) from customers using the EP Nucleic Acid Test Cartridges component (20-006-023) from the Verigene EP Nucleic Acid Test Kit (20-005-023).

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  • Withdrawn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
PCH
FDA applicant
Nanospere,Inc.
Device Class
Class II
Regulation
21 CFR Part 866.3990
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent