Product Classification

• 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 Code: OUS
• 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 Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc