Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg Ionella Urinary Antigen Control Kit Model 8522

• • Terminated Z-0222-2007 FDA Unclassified (pre-2012) ·initiated 29 Sep 2006

  Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S. pneumonia test pouches

510(k) Number

K982238 ↗

FDA Product Code

MJH

Device Class

Class II

Regulation

21 CFR Part 866.3300

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. →