MGB Alert® Internal Control set IC1 DSQ

GUDID 03661540952364

The MGB Alert Internal Control Set IC1 DSQ contains the MGB Alert IC1 DNA Template, the MGB Alert IC1 v3.0 Primers, and the MGB Alert IC1 DSQ Probe. When used as intended, the Internal Control Set IC1 DSQ will detect systemic variation that may arise during the nucleic acid extraction and amplification processes associated with real-time PCR assays.

Elitechgroup Mdx LLC

Nucleic acid amplification primer IVD

• Primary Device ID: 03661540952364
• NIH Device Record Key: b1460d3a-e405-4ade-937a-efa3782f5a05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MGB Alert® Internal Control set IC1 DSQ
• Version Model Number: M800728
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661540952364 [Primary]

FDA Product Code

• OLD: Internal Polymerase Chain Reaction Control, Not Assay Specific

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: 2022-10-10
• Device Publish Date: 2022-09-30

On-Brand Devices [MGB Alert® Internal Control set IC1 DSQ]

• 03661540952364: The MGB Alert Internal Control Set IC1 DSQ contains the MGB Alert IC1 DNA Template, the MGB Aler
• 03661540952333: The MGB Alert Internal Control Set IC1 DSQ contains the MGB Alert IC1 DNA Template, the MGB Aler