Binaxnow PBP2A Test, Model 890-000

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K090301 ↗

FDA Product Code

MYI

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• Modification to Binax Now Streptococcus Pneumoniae Urinary Antigen Test

  Class I

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