MGB Alert Internal Control Set IC2-T

Basic Information

• Brand Name: MGB Alert Internal Control Set IC2-T
• Primary DI: 03661540950247
• Version / Model: M800580
• Catalog Number: M800580
• Company Name: Elitechgroup Mdx LLC
• Labeler DUNS: 117458512
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-15
• Public Version: 4
• Public Version Date: 2022-08-30
• Public Version Status: Update
• Public Device Record Key: 3557151d-0b12-47ef-b06a-d76aa1be5685

Device Description

The MGB Alert Internal Control Set IC2-T consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-T can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set 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
60094	Exogenous DNA/RNA internal control IVD, kit	A collection of reagents and other associated materials intended to be used as an exogenous component in a molecular assay, to verify the extraction and/or amplification process applied to target deoxyribonucleic acid (DNA) and/or ribonucleic acid (RNA), and/or to verify the absence of inhibiting substances in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03661540950247	GS1

Customer Contacts

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