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

GUDID 03661540952579

DSQ Alert™ HT Candida auris Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the ITS2 gene of Candida auris. The mix consists of a total of 3.9 nmol of probe per vial in a 1X TE buffer solution. The probe is labeled with FAM and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm.

Elitechgroup Mdx LLC

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

• Primary Device ID: 03661540952579
• NIH Device Record Key: 465136e3-f25f-42fb-a201-ba669a5ace39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DSQ Alert HT Candida auris Probe Mix ASR, 192 rxn Final Assembly
• Version Model Number: M800761
• 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	03661540952579 [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

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