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ID NOW Influenza A & B 2

by Abbott Diagnostics Scarborough, Inc. 3 variants

510(k) K232775

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

Recall on shared 510(k) K232775; other models may be affected

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK232775 Date10 Oct 2023ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1572-2025 FDA Class II initiated 4 Mar 2025 on shared 510(k) K232775
    • Ongoing Z-1575-2025 FDA Class II initiated 4 Mar 2025 on shared 510(k) K232775

    The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
OCC
Device Class
Class II
Regulation
21 CFR Part 866.3980
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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