Bd Directigen Ez Rsv Kit

• • Terminated Z-0373-04 FDA Unclassified (pre-2012) ·initiated 15 Dec 2003

  Diagnostic test kit may exhibit false positive results.

510(k) Number

K022133 ↗

FDA Product Code

GQG

Device Class

Class I

Regulation

21 CFR Part 866.3480

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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