Panels › Microbiology › Product code MYI · Class 2
System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Regulation 866.1640
0510(k)s in 12 months (10 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MYI
| Company | 510(k)s | Recalls |
|---|---|---|
| Alere Scarborough, Inc. | 2 | 0 |
| Binax, Inc. | 2 | 0 |
| Id Biomedical Corp. | 2 | 0 |
| Advandx, Inc. | 1 | 0 |
| Denka Seiken'S | 1 | 0 |
| Mast Group , Ltd. | 1 | 0 |
| Oxoid , Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 10, 2014 | K140619 | MECA XPRESSFISH Advandx, Inc. | MYI |
| Sep 3, 2014 | K133851 | ALERE PBP2A SA/CONS CULTURE COLONY TEST Alere Scarborough, Inc. | MYI |
| Jul 26, 2012 | K121905 | ALERE PBP2A TEST Alere Scarborough, Inc. | MYI |
| Apr 14, 2010 | K090301 | BINAXNOW PBP2A TEST, MODEL 890-000 Binax, Inc. | MYI |
| Feb 24, 2010 | K091766 | CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 Binax, Inc. | MYI |
| Oct 18, 2006 | K062864 | MASTALEX -MRSA, MODEL RST501 Mast Group , Ltd., GB | MYI |
| Apr 2, 2002 | K011710 | OXOID PBP2 1 LATEX AGGLUTINATION TEST Oxoid , Ltd., GB | MYI |
| Mar 27, 2002 | K011400 | MRSA-SCREEN Denka Seiken'S, JP | MYI |
| May 24, 2001 | K010858 | VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION Id Biomedical Corp. | MYI |
| Jul 9, 1999 | K990640 | VELOGENE RAPID MRSA IDENTIFICATION ASSAY Id Biomedical Corp., CA | MYI |
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