MRSA/SA ELITe MGB

GUDID 03661540950001

MRSA/SA ELITe MGB™ is a qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA purified from nasal swabs. MRSA/SA ELITe MGB™ is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections or to guide or monitor treatment for MRSA infections. A negative result does not preclude MRSA/SA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

Elitechgroup Mdx LLC

MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 03661540950001
• NIH Device Record Key: b3cdd036-7c3d-47b3-899f-c2adf32ff9d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MRSA/SA ELITe MGB
• Version Model Number: M800346
• Company DUNS: 117458512
• Company Name: Elitechgroup Mdx LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8004532725
• Email: mdx@elitechgroup.com
• Phone: 8004532725
• Email: mdx@elitechgroup.com
• Phone: 8004532725
• Email: mdx@elitechgroup.com
• Phone: 8004532725
• Email: mdx@elitechgroup.com
• Phone: 8004532725
• Email: mdx@elitechgroup.com
• Phone: 8004532725
• Email: mdx@elitechgroup.com
• Phone: 8004532725
• Email: mdx@elitechgroup.com
• Phone: 8004532725
• Email: mdx@elitechgroup.com
• Phone: 8004532725
• Email: mdx@elitechgroup.com
• Phone: 8004532725
• Email: mdx@elitechgroup.com
• Phone: 8004532725
• Email: mdx@elitechgroup.com
• Phone: 8004532725
• Email: mdx@elitechgroup.com
• Phone: 8004532725
• Email: mdx@elitechgroup.com
• Phone: 8004532725
• Email: mdx@elitechgroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661540950001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112937

FDA Product Code

• NQX: System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-10-15
• Device Publish Date: 2016-10-13

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