Binaxnow Influenza A & B Test

No FDA recalls on record, checked 22 Oct 2026.

Full name

Modification to: Binaxnow Influenza a & B Test

510(k) Number

K092223 ↗

FDA Product Code

PSZ

Device Class

Class II

Regulation

21 CFR Part 866.3328

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Binax Now Streptococcus Pneumoniae Test Open recall

  Class I

  FDA 510(k) K012521 Active Cleared 30 Nov 2001

• Binax Now Rsv Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack, Model 400-065

  Class I

  FDA 510(k) K032166 Active Cleared 21 Oct 2003

• Binaxnow PBP2A Test, Model 890-000

  Class II

  FDA 510(k) K090301 Active Cleared 14 Apr 2010

• Binax Equate Strep B

  Class I

  FDA 510(k) K872904 Active Cleared 20 Nov 1987

• Binaxnow Influenza a & B Test

  Class II

  FDA 510(k) K053126 Active Cleared 30 Nov 2005

• Equate AQR APO AL/B Duo Control

  Class II

  FDA 510(k) K903122 Active Cleared 2 Aug 1990

See all devices from Binax, Inc. →

• What is the Binaxnow Influenza A & B Test used for?

  The Binaxnow Influenza A & B Test is used to detect influenza A and B virus antigens, aiding in the diagnosis of influenza.

• Is the Binaxnow Influenza A & B Test cleared by the FDA?

  Yes, the Binaxnow Influenza A & B Test has been cleared with a special 510K clearance, indicating it is substantially equivalent to other devices.

• What is the product code for the Binaxnow Influenza A & B Test?

  The product code for the Binaxnow Influenza A & B Test is PSZ, and it has a regulation number of 866.3328.

• What type of device is the Binaxnow Influenza A & B Test classified as?

  The Binaxnow Influenza A & B Test is classified as a device that detects influenza A, B, and C virus antigens, falling under the category of microbiology devices.