MYIClass II
System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Microbiology · 21 CFR 866.1640
MDR events2All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances10All time
Recent MDR events
2 adverse event reports on file
Event type breakdown
Malfunction2
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
10 clearances for this product code
- Advandx, Inc.Oct 10, 2014
K140619 · MECA XPRESSFISH
- Alere Scarborough, Inc.Sep 3, 2014
K133851 · ALERE PBP2A SA/CONS CULTURE COLONY TEST
- Alere Scarborough, Inc.Jul 26, 2012
K121905 · ALERE PBP2A TEST
- Binax, Inc.Apr 14, 2010
K090301 · BINAXNOW PBP2A TEST, MODEL 890-000
- Binax, Inc.Feb 24, 2010
K091766 · CLEARVIEW EXACT PBP2A TEST, MODEL 891-000
- Mast Group , Ltd.Oct 18, 2006
K062864 · MASTALEX -MRSA, MODEL RST501
- Oxoid , Ltd.Apr 2, 2002
K011710 · OXOID PBP2 1 LATEX AGGLUTINATION TEST
- Denka Seiken'SMar 27, 2002
K011400 · MRSA-SCREEN