DSQ Alert HT Probe Mix ASR M800812

GUDID 03661540952814

DSQ Alert™ HT HDV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the Hepatitis Delta Virus RNA. The mix consists of a total of 7.8 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is labeled with the 6-FAM fluorophore and has an excitation wavelength maximum of 496 nm and an emission wavelength maximum of 517 nm. The reagent contained in this package should be protected from light and stored at less or equal to -10 degrees Celsius. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaws.

Elitechgroup Mdx LLC

Hepatitis D virus nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 03661540952814
• NIH Device Record Key: 0cb6a99c-7d04-4413-a962-c847ea17872d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DSQ Alert HT Probe Mix ASR
• Version Model Number: M800812
• Catalog Number: M800812
• 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: 1-833-227-3400
• Email: mdx@elitechgroup.com
• Phone: 1-833-227-3400
• Email: mdx@elitechgroup.com
• Phone: 1-833-227-3400
• Email: mdx@elitechgroup.com
• Phone: 1-833-227-3400
• Email: mdx@elitechgroup.com
• Phone: 1-833-227-3400
• Email: mdx@elitechgroup.com
• Phone: 1-833-227-3400
• Email: mdx@elitechgroup.com
• Phone: 1-833-227-3400
• Email: mdx@elitechgroup.com
• Phone: 1-833-227-3400
• Email: mdx@elitechgroup.com
• Phone: 1-833-227-3400
• Email: mdx@elitechgroup.com
• Phone: 1-833-227-3400
• Email: mdx@elitechgroup.com
• Phone: 1-833-227-3400
• Email: mdx@elitechgroup.com
• Phone: 1-833-227-3400
• Email: mdx@elitechgroup.com
• Phone: 1-833-227-3400
• Email: mdx@elitechgroup.com
• Phone: 1-833-227-3400
• Email: mdx@elitechgroup.com
• Phone: 1-833-227-3400
• Email: mdx@elitechgroup.com
• Phone: 1-833-227-3400
• Email: mdx@elitechgroup.com
• Phone: 1-833-227-3400
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661540952814 [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: 2024-07-24
• Device Publish Date: 2024-07-16

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