Product code MYI— Microbiology
ALERE PBP2A SA/CONS CULTURE COLONY TEST
- Classification name
- System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Total cleared
- 10
- First cleared
- Most recent
Market context for product code MYI
FDA has cleared devices under product code MYI between 1999 and 2014, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2014
- 2012
- 2010
- 2006
- 2002
- 2001
- 1999
Top applicants under product code MYI
Recent clearances under product code MYI
- K140619 — MECA XPRESSFISH
- K133851 — ALERE PBP2A SA/CONS CULTURE COLONY TEST
- K121905 — ALERE PBP2A TEST
- K090301 — BINAXNOW PBP2A TEST, MODEL 890-000
- K091766 — CLEARVIEW EXACT PBP2A TEST, MODEL 891-000
- K062864 — MASTALEX -MRSA, MODEL RST501
- K011710 — OXOID PBP2 1 LATEX AGGLUTINATION TEST
- K011400 — MRSA-SCREEN
- K010858 — VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION
- K990640 — VELOGENE RAPID MRSA IDENTIFICATION ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.