MYI · Class II · 21 CFR 866.1640

FDA Product Code MYI: System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies

Leading manufacturers include Binax, Inc., Alere Scarborough, Inc. and Id Biomedical Corp..

10
Total
10
Cleared
203d
Avg days
1999
Since

FDA 510(k) Cleared System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies Devices (Product Code MYI)

10 devices
1–10 of 10
Cleared Oct 10, 2014
MECA XPRESSFISH
K140619
Advandx, Inc.
Microbiology · 213d
Cleared Sep 03, 2014
ALERE PBP2A SA/CONS CULTURE COLONY TEST
K133851
Alere Scarborough, Inc.
Microbiology · 258d
Cleared Jul 26, 2012
ALERE PBP2A TEST
K121905
Alere Scarborough, Inc.
Microbiology · 27d
Cleared Apr 14, 2010
BINAXNOW PBP2A TEST, MODEL 890-000
K090301
Binax, Inc.
Microbiology · 432d
Cleared Feb 24, 2010
CLEARVIEW EXACT PBP2A TEST, MODEL 891-000
K091766
Binax, Inc.
Microbiology · 252d
Cleared Oct 18, 2006
MASTALEX -MRSA, MODEL RST501
K062864
Mast Group , Ltd.
Microbiology · 23d
Cleared Apr 02, 2002
OXOID PBP2 1 LATEX AGGLUTINATION TEST
K011710
Oxoid , Ltd.
Microbiology · 302d
Cleared Mar 27, 2002
MRSA-SCREEN
K011400
Denka Seiken'S
Microbiology · 324d
Cleared May 24, 2001
VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION
K010858
Id Biomedical Corp.
Microbiology · 63d
Cleared Jul 09, 1999
VELOGENE RAPID MRSA IDENTIFICATION ASSAY
K990640
Id Biomedical Corp.
Microbiology · 133d

About Product Code MYI - Regulatory Context