MGB Alert HSV1 Primer Mix, 48 rxn ASR, Finished Product M800585

GUDID 03661540952005

MGB Alert HSV-1 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the glycoprotein-D gene of HSV-1. The mix consists of a total of 9.0 nmol of primers per vial in a 1X TE buffer solution. The primers target a 90 bp region of the glycoprotein-D gene of HSV-1.

Elitechgroup Mdx LLC

Herpes simplex virus 1 (HSV1) nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 03661540952005
• NIH Device Record Key: b38d91a4-a962-40b6-8ee8-3a3c4eb5bd70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MGB Alert HSV1 Primer Mix, 48 rxn ASR, Finished Product
• Version Model Number: M800585
• Catalog Number: M800585
• 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	03661540952005 [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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