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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE. 510(k) Number:
k033415
B. Analyte:
Methicillin Resistant Staphylococcus aureus (MRSA) detection
C. Type of Test:
Nucleic
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What is methicillin resistant staphylococcus aureus?
Methicillin-resistant Staphylococcus aureus (MRSA) is a type of staph bacteria that is resistant to certain antibiotics.
Who is required to file methicillin resistant staphylococcus aureus?
Healthcare facilities are required to report cases of MRSA to the appropriate authorities.
How to fill out methicillin resistant staphylococcus aureus?
To fill out a MRSA report, healthcare providers must include specific information about the patient and the infection.
What is the purpose of methicillin resistant staphylococcus aureus?
The purpose of reporting MRSA cases is to track and prevent the spread of this antibiotic-resistant bacteria.
What information must be reported on methicillin resistant staphylococcus aureus?
Information such as patient demographics, infection details, antibiotic resistance patterns, and treatment outcomes must be reported for MRSA cases.
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