ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0— 510(k) K262747

Name: FDA 510(k) clearance K262747
Creator: U.S. Food and Drug Administration
Published: 2026-08-31

Substantially Equivalent

Abbott Diagnostics Scarborough, Inc.

FDA 510(k) clearance K262747 for ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0, Substantially Equivalent on 2026-08-31. Applicant: Abbott Diagnostics Scarborough, Inc.. Device class: 2.

Clearance details

Applicant: Abbott Diagnostics Scarborough, Inc.
Product code: Code OCC
Device class: Class 2
Regulation: 21 CFR 866.3980
Advisory panel: Microbiology
Date received: 2026-08-03
Decision date: 2026-08-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Scarborough, ME, US

Download summary PDF View on FDA.gov ↗

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K231017 — Panther Fusion AdV/hMPV/RV Assay2023-05-05
K213822 — cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System2022-07-06

More clearances from Abbott Diagnostics Scarborough, Inc.

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K250273 — BinaxNOW COVID-19 Ag Card2025-06-13
K243518 — BinaxNOW COVID-19 Antigen Self Test2025-02-11
K221925 — ID NOW COVID-19 2.02023-08-10
K220801 — ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 22022-06-24
K191534 — ID NOW Influenza A & B 22019-07-11

Adverse events under product code OCC

product code OCC

Death: 3
Malfunction: 706
Total: 709

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.