System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
FDA product code MYI · 8 cleared devices
Class 2
Microbiology
- Regulation
- 21 CFR 866.1640
- Review panel
- MI
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1999-07-09 – 2012-07-26
MYI
2012-07-26
MYI
2010-04-14
BINAXNOW PBP2A TEST, MODEL 890-000
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MYI
2010-02-24
CLEARVIEW EXACT PBP2A TEST, MODEL 891-000
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MYI
2006-10-18
MASTALEX -MRSA, MODEL RST501
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MYI
2002-04-02
OXOID PBP2 1 LATEX AGGLUTINATION TEST
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MYI
2002-03-27
MRSA-SCREEN
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MYI
2001-05-24
VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION
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MYI
1999-07-09
VELOGENE RAPID MRSA IDENTIFICATION ASSAY
View details →No matching devices.
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