DSQ Alert Internal Control set IC1

Basic Information

• Brand Name: DSQ Alert Internal Control set IC1
• Primary DI: 03661540952791
• Version / Model: M800734
• Catalog Number: M800734
• Company Name: Elitechgroup Mdx LLC
• Labeler DUNS: 117458512
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-29
• Public Version: 1
• Public Version Date: 2024-08-06
• Public Version Status: New
• Public Device Record Key: 1d81943c-677e-44d4-86c4-d420e9850b1e

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OLD	Internal Polymerase Chain Reaction Control, Not Assay Specific	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64176	Nucleic acid amplification primer IVD	A defined piece of single-stranded nucleic acid intended to be used to initiate the amplification of a specific target nucleotide sequence at a single-gene locus or whole/partial chromosome level in a clinical specimen, using a nucleic acid amplification technique (e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)]. It is typically used to detect and/or identify chromosomal abnormalities (e.g., aneuploidy, deletion, translocation, duplication, inversion, gene insertion).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03661540952791	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – -10 Degrees Celsius