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Id Now Covid-19 2.0

by Abbott Diagnostics Scarborough, Inc.

510(k) K221925

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

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 · Dual Track NumberK221925 Date10 Aug 2023ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1571-2025 FDA Class II initiated 4 Mar 2025
    • Ongoing Z-1574-2025 FDA Class II initiated 4 Mar 2025

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

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  • Withdrawn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
QWR
Device Class
Class II
Regulation
21 CFR Part 866.3982
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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