DSQ Alert Internal Control set IC1 M800734

GUDID 03661540952791

The DSQ Alert Internal Control Set IC1 contains the MGB Alert IC1 DNA Template, the DSQ Alert IC1 v3.0 Primers, and the DSQ Alert IC1 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. 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

Nucleic acid amplification primer IVD

• Primary Device ID: 03661540952791
• NIH Device Record Key: 1d81943c-677e-44d4-86c4-d420e9850b1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DSQ Alert Internal Control set IC1
• Version Model Number: M800734
• Catalog Number: M800734
• 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: (833) 227-3400
• Email: mdx@elitechgroup.com
• Phone: (833) 227-3400
• Email: mdx@elitechgroup.com
• Phone: (833) 227-3400
• Email: mdx@elitechgroup.com
• Phone: (833) 227-3400
• Email: mdx@elitechgroup.com
• Phone: (833) 227-3400
• Email: mdx@elitechgroup.com
• Phone: (833) 227-3400
• Email: mdx@elitechgroup.com
• Phone: (833) 227-3400
• Email: mdx@elitechgroup.com
• Phone: (833) 227-3400
• Email: mdx@elitechgroup.com
• Phone: (833) 227-3400
• Email: mdx@elitechgroup.com
• Phone: (833) 227-3400
• Email: mdx@elitechgroup.com
• Phone: (833) 227-3400
• Email: mdx@elitechgroup.com
• Phone: (833) 227-3400
• Email: mdx@elitechgroup.com
• Phone: (833) 227-3400
• Email: mdx@elitechgroup.com
• Phone: (833) 227-3400
• Email: mdx@elitechgroup.com
• Phone: (833) 227-3400
• Email: mdx@elitechgroup.com
• Phone: (833) 227-3400
• Email: mdx@elitechgroup.com
• Phone: (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	03661540952791 [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: 2024-08-06
• Device Publish Date: 2024-07-29

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