DSQ Alert HT Candida auris Primer Mix ASR, 192 rxn Final Assembly M800760

GUDID 03661540952562

DSQ Alert™ HT Candida auris Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the ITS2 gene of Candida auris. The mix consists of a total of 39.2 nmol of primers per vial in a 1X TE buffer solution. The primers target a 124 bp region of the ITS2 gene of Candida auris.

Elitechgroup Mdx LLC

Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 03661540952562
• NIH Device Record Key: 1a46fcc7-2060-4ac7-9754-efbc70cb939a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DSQ Alert HT Candida auris Primer Mix ASR, 192 rxn Final Assembly
• Version Model Number: M800760
• Catalog Number: M800760
• Company DUNS: 117458512
• Company Name: Elitechgroup Mdx LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• 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
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com
• Phone: 8004532725
• Email: MDx@elitechgroup.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661540952562 [Primary]

FDA Product Code

• MVU: Reagents, Specific, Analyte

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-29
• Device Publish Date: 2023-09-21

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