DSQ Alert HHV7 Primer Mix ASR M800766

GUDID 03661540952722

Product Description DSQ Alert® HHV-7 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the major capsid protein gene of HHV-7. The mix consists of a total of 3.2 nmol of primers per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The primers target a 106 bp region of the major capsid protein gene of HHV-7. Each product lot will go through functional testing with an approved test method. Storage and Handling Requirements The reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than 10 degrees Celsius when received. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles. Warnings and Precautions Carefully read this entire package insert. - The operator must be trained to perform high complexity work and avoid distractions that may lead to errors. - Use general precautions and wear appropriate personal protective equipment when handling the reagents. - Do not eat, drink, or smoke in designated work areas. - Wash hands thoroughly after handling reagents. - Prevent reagent carryover by working in a nuclease-free area keeping one tube open at a time during reagent preparation and PCR setup. Completed PCR tubes or sealed plates should not be opened. - Dispose of all material that has come into contact with specimens and reagents in accordance with applicable national, international, and regional regulations.

Elitechgroup Mdx LLC

Human herpesvirus 7 (HHV7) nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 03661540952722
• NIH Device Record Key: 3fa82a2e-2992-4930-b4e8-ee7b5ae2f43f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DSQ Alert HHV7 Primer Mix ASR
• Version Model Number: M800766
• Catalog Number: M800766
• 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: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661540952722 [Primary]

FDA Product Code

• MVU: Reagents, Specific, Analyte

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-01-13
• Device Publish Date: 2025-10-14

Devices Manufactured by Elitechgroup Mdx LLC

• 03661540952722 - DSQ Alert HHV7 Primer Mix ASR: 2026-01-13Product Description DSQ Alert® HHV-7 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the major capsid protein gene of HHV-7. The mix consists of a total of 3.2 nmol of primers per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The primers target a 106 bp region of the major capsid protein gene of HHV-7. Each product lot will go through functional testing with an approved test method. Storage and Handling Requirements The reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than 10 degrees Celsius when received. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles. Warnings and Precautions Carefully read this entire package insert. - The operator must be trained to perform high complexity work and avoid distractions that may lead to errors. - Use general precautions and wear appropriate personal protective equipment when handling the reagents. - Do not eat, drink, or smoke in designated work areas. - Wash hands thoroughly after handling reagents. - Prevent reagent carryover by working in a nuclease-free area keeping one tube open at a time during reagent preparation and PCR setup. Completed PCR tubes or sealed plates should not be opened. - Dispose of all material that has come into contact with specimens and reagents in accordance with applicable national, international, and regional regulations.
• 03661540952722 - DSQ Alert HHV7 Primer Mix ASR: 2026-01-13 Product Description DSQ Alert® HHV-7 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonu
• 03661540952739 - DSQ Alert HHV7 Probe Mix ASR: 2026-01-13 Product Description DSQ Alert® HHV-7 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligon
• 03661540952821 - DSQ Alert® HT JCV Primer Mix ASR: 2025-03-14 DSQ Alert® HT JCV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed
• 03661540952838 - DSQ Alert® HT JCV Probe Mix ASR: 2025-03-14 Product Description DSQ Alert® HT JCV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligo
• 03661540952845 - DSQ Alert HT Norovirus GI Primer Mix ASR: 2025-03-14 Product Description DSQ Alert® HT Norovirus GI Primer Mix is an analyte specific reagent that contains chemically synthesized D
• 03661540952852 - DSQ Alert® HT Norovirus GI Probe Mix ASR: 2025-03-14 Product Description DSQ Alert® HT Norovirus GI Probe Mix is an analyte specific reagent that contains a chemically synthesized
• 03661540952869 - DSQ Alert HT Norovirus GII Primer Mix ASR: 2025-03-14 Product Description DSQ Alert® HT Norovirus GII Primer Mix is an analyte specific reagent that contains chemically synthesized
• 03661540952876 - DSQ Alert® HT Norovirus GII Probe Mix ASR: 2025-03-14 Product Description DSQ Alert® HT Norovirus GII Probe Mix is an analyte specific reagent that contains a chemically synthesized