The ARIES® MRSA Assay is an integrated real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of methicillin–resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization

The ARIES® MRSA Assay is an integrated real
ARIES® MRSA Assay - 50-10034

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid conferring methicillin resistance, in methicillin-resistant Staphylococcus aureus (MRSA) bacteria present in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NQX

Device Name: System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

Device Class: 2

Physical State: N/A

Definition: 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.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.1640

Third Party Flag: N

Medical Specialty: MI

Device Id: 00840487101445

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A