MYI
10 FDA 510(k) clearances · Product code
252 daysmedian time to decision
432 days90th percentile
10clearances measured
FDA profile
- Official device name
- System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MECA XPRESSFISH (K140619) | Advandx, Inc. | 2014-10-10 |
| ALERE PBP2A SA/CONS CULTURE COLONY TEST (K133851) | Alere Scarborough, Inc. | 2014-09-03 |
| ALERE PBP2A TEST (K121905) | Alere Scarborough, Inc. | 2012-07-26 |
| BINAXNOW PBP2A TEST, MODEL 890-000 (K090301) | Binax, Inc. | 2010-04-14 |
| CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 (K091766) | Binax, Inc. | 2010-02-24 |
| MASTALEX -MRSA, MODEL RST501 (K062864) | Mast Group , Ltd. | 2006-10-18 |
| OXOID PBP2 1 LATEX AGGLUTINATION TEST (K011710) | Oxoid , Ltd. | 2002-04-02 |
| MRSA-SCREEN (K011400) | Denka Seiken'S | 2002-03-27 |
| VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION (K010858) | Id Biomedical Corp. | 2001-05-24 |
| VELOGENE RAPID MRSA IDENTIFICATION ASSAY (K990640) | Id Biomedical Corp. | 1999-07-09 |
Track MYI automatically
Every clearance here is in the API, with alerts when new ones post.