Binax Now Streptococcus Pneumoniae Test

• • Ongoing Z-3184-2024 FDA Class II ·initiated 20 Aug 2024

  Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.

510(k) Number

K012521 ↗

FDA Product Code

GTZ

Device Class

Class I

Regulation

21 CFR Part 866.3740

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• 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

• Modification to Binax Now Streptococcus Pneumoniae Urinary Antigen Test

  Class I

  FDA 510(k) K010523 Active Cleared 15 Mar 2001

See all devices from Binax, Inc. →