DSQ Alert HT Primer Mix ASR m800811

GUDID 03661540952807

DSQ Alert™ HT HDV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the Hepatitis Delta Virus RNA. The mix consists of a total of 31.2 nmol of primers per vial in a 1X TE buffer solution. The primers target a 57 bp region of the Hepatitis Delta Virus RNA. 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: 03661540952807
• NIH Device Record Key: f2845f02-f171-4cd1-8d5c-76e9fec9f9bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DSQ Alert HT Primer Mix ASR
• Version Model Number: M800811
• Catalog Number: m800811
• 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	03661540952807 [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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