510(k) K112937

MRSA/SA ELITE MGB by Elitech — Product Code NQX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 1, 2012
Date Received: October 3, 2011
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Device Class: Class II
Regulation Number: 866.1640
Review Panel: MI
Submission Type

A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.

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