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

Devices Manufactured by Elitechgroup Mdx LLC

• 03661540952760 - DSQ Alert® Internal Control set IC1: 2024-11-01 The DSQ Alert Internal Control Set IC1 contains the MGB Alert IC1 DNA Template, the DSQ Alert IC1 v3.0 Primers, and the MGB Aler
• 03661540952791 - DSQ Alert Internal Control set IC1: 2024-08-06 The DSQ Alert Internal Control Set IC1 contains the MGB Alert IC1 DNA Template, the DSQ Alert IC1 v3.0 Primers, and the DSQ Aler
• 03661540952807 - DSQ Alert HT Primer Mix ASR: 2024-07-24 DSQ Alert™ HT HDV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed
• 03661540952814 - DSQ Alert HT Probe Mix ASR: 2024-07-24 DSQ Alert™ HT HDV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed
• 03661540952746 - DSQ Alert BK Virus v3.0 Primer Mix: 2024-05-23 DSQ Alert BK Virus ASR v3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acids fr
• 03661540952753 - DSQ Alert BKV ASR v3.0 Probe Mix, 48 rxns: 2024-05-23 DSQ Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids fr
• 03661540952692 - DSQ Alert™ Parechovirus v2.0 Primer Mix ASR: 2023-10-13 DSQ Alert Parechovirus v2.0 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides
• 03661540952708 - DSQ Alert™ Parechovirus v2.0 Probe Mix ASR: 2023-10-13 DSQ Alert Parechovirus v2.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide