• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
New Search Back to Search Results
Device methicillin resistant staphylococcus aureus/methicillin susceptible staphylococcus aureus blood culture test bt
Regulation Description Staphylococcal typing bacteriophage.
Definition The mrsa/mssa blood culture test-bt is a qualitative ivd test using bacteriophage amplification for the identification of staphylococcus aureus and the determination of meca mediated methicillin resistance or methicillin susceptbility directly from positive blood cultures confirmed to have gram positive cocci in clusters (gpcc) or gram positive cocci in singles (gpc) by gram stain.
Physical State Kit consisting of plastic capped tubes, pipets, lateral flow cassette and liquid reagents
Technical Method Bacteriophage amplification
Target Area Systemic, blood
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOUS
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.2050
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons