Oxoid Infectious Mononucleosis Kit

• • Terminated Z-0786-06 FDA Unclassified (pre-2012) ·initiated 14 Feb 2006

  Some units exhibit weak false-positive reactions with some negative patient serum

510(k) Number

K883540 ↗

FDA Product Code

KTN

FDA applicant

Unipath , Ltd.

Device Class

Class II

Regulation

21 CFR Part 866.5640

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Unipath, Ltd. →