MGB Alert IC1 Internal Control Template

Basic Information

• Brand Name: MGB Alert IC1 Internal Control Template
• Primary DI: 03661540952388
• Version / Model: M800736
• Catalog Number: M800736
• Company Name: Elitechgroup Mdx LLC
• Labeler DUNS: 117458512
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-30
• Public Version: 1
• Public Version Date: 2022-09-07
• Public Version Status: New
• Public Device Record Key: 937947bd-3032-4f4e-a1fb-9295ffdca80d

Device Description

The MGB Alert Internal Control IC1 Template consists of a DNA plasmid intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The IC1 Internal Control can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The internal control is not intended to monitor other real-time PCR processes.

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	03661540952388	GS1

Storage Conditions

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