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

• • Terminated Z-0824-2007 FDA Unclassified (pre-2012) ·initiated 28 Mar 2007

  Tip of the foam swab could detach from the shaft causing injury to the patient.

• • Terminated Z-0778-04 FDA Unclassified (pre-2012) ·initiated 18 Feb 2004

  Pouch integrity compromised

510(k) Number

K032166 ↗

FDA Product Code

GQG

Models / Variants

430-000

Binax Now Nasopharyngeal Swab Accessory Pack

Model 400-065

Device Class

Class I

Regulation

21 CFR Part 866.3480

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• Modification to Binax Now Streptococcus Pneumoniae Urinary Antigen Test

  Class I

  FDA 510(k) K010523 Active Cleared 15 Mar 2001

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