MJZ · Class I · 21 CFR 862.1660

FDA Product Code MJZ: Kit, Direct Antigen, Positive Control

Leading manufacturers include Binax, Inc., Blackhawk Biosystems, Inc. and Abbott Diagnostics.

3
Total
3
Cleared
134d
Avg days
1997
Since

FDA 510(k) Cleared Kit, Direct Antigen, Positive Control Devices (Product Code MJZ)

3 devices
1–3 of 3
Cleared Sep 01, 2009
BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010
K083744
Binax, Inc.
Microbiology · 259d
Cleared Aug 13, 1997
ABBOTT STREP A CONTROLS
K972182
Abbott Diagnostics
Microbiology · 76d
Cleared Aug 12, 1997
CHLAMYDIATROL AG
K972129
Blackhawk Biosystems, Inc.
Microbiology · 67d

About Product Code MJZ - Regulatory Context