MGB Alert 2X ELITaq Master Mix, 48rxn

Basic Information

• Brand Name: MGB Alert 2X ELITaq Master Mix, 48rxn
• Primary DI: 03661540952517
• Version / Model: M800809
• Catalog Number: M800809
• Company Name: Elitechgroup Mdx LLC
• Labeler DUNS: 117458512
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-03
• Public Version: 1
• Public Version Date: 2023-02-13
• Public Version Status: New
• Public Device Record Key: 44b4697f-375a-4b9a-952d-52c7b375fbf6

Device Description

The MGB Alert ELITaq Master Mix is a premixed ready-to-use solution containing necessary components and reaction buffer for efficient amplification of DNA templates by PCR. The solution is supplied at 2X relative to the optimal final concentration in the PCR, and contains 2X reaction buffer, dNTPs, MgCl2, and DNA polymerase with 5’ - 3’ exonuclease activity. PCR grade water is also provided in the product.

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
PPM	General Purpose Reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60091	Nucleic acid amplification mastermix kit IVD	A collection of reagents and other associated materials intended to be used in combination with sequence-specific primers, probes and/or controls to facilitate the amplification of a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)} in a clinical specimen, using a nucleic acid amplification technique (e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03661540952517	GS1

Storage Conditions

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