FDA 510(k)

ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0

Numéro K : K262747 · 2026-08-31

DemandeurAbbott Diagnostics Scarborough, Inc.

Date de décision2026-08-31

Code produitOCC

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics Scarborough, Inc.. It received FDA 510(k) clearance on 2026-08-31 under 510(k) number K262747. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0?

ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 is a medical device that received FDA 510(k) clearance on 2026-08-31. The listed applicant is Abbott Diagnostics Scarborough, Inc.. The 510(k) number is K262747.

When did ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 receive FDA 510(k) clearance?

ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 received FDA 510(k) clearance on 2026-08-31, under 510(k) number K262747.

Who is the listed applicant for ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0?

The FDA 510(k) record lists Abbott Diagnostics Scarborough, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0?

The FDA product code for ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 is OCC.

Essais cliniques associés

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Autres dossiers indiquant Abbott Diagnostics Scarborough, Inc. en tant que demandeur

K250273BinaxNOW COVID-19 Ag Card K243518BinaxNOW™ COVID-19 Antigen Self Test K232775ID NOW Influenza A & B 2 K221925ID NOW COVID-19 2.0 K220801ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 K191534ID NOW Influenza A & B 2

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Dispositifs connexes (Code : OCC)

K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.K242613NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc.K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.K210234cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.

Source officielle

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