Kit, Direct Antigen, Positive Control

FDA product code MJZ · Class I (low risk) · 21 CFR 862.1660 · Clinical Chemistry

3510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K083744Binaxnow Malaria Positive Control Kit, Model 665-010MJZ · Traditional Binax, Inc.09/01/2009SE
K972182Abbott Strep a ControlsMJZ · Traditional Abbott Diagnostics08/13/1997SE
K972129Chlamydiatrol AGMJZ · Traditional Blackhawk Biosystems, Inc.08/12/1997SE