MGB Alert IC1 Internal Control Template (35uL volume)

Basic Information

• Brand Name: MGB Alert IC1 Internal Control Template (35uL volume)
• Primary DI: 03661540952371
• Version / Model: M800735
• Company Name: ELITECH GROUP INC.
• Labeler DUNS: 079696864
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-05
• Public Version: 2
• Public Version Date: 2022-08-30
• Public Version Status: Update
• Public Device Record Key: 53e42fca-b0ae-4a97-b4a5-415f1c1cfef1

Device Description

The MGB Alert Internal Control Set IC1 consists of reagents intended for use as an un-assayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC1 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: Yes
• 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	03661540952371	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Less or equal to -10C Celsius