MGB Alert Platinum Master Mix-48 rxn M800599

GUDID 03661540950278

The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data.

ELITECH GROUP INC.

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• Primary Device ID: 03661540950278
• NIH Device Record Key: fa6e38da-1995-4499-b797-73e1c4a8d8d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MGB Alert Platinum Master Mix-48 rxn
• Version Model Number: M800599
• Catalog Number: M800599
• Company DUNS: 079696864
• Company Name: ELITECH GROUP INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com
• Phone: 800-453-2725
• Email: MDx@elitechgroup.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661540950278 [Primary]

FDA Product Code

• PPM: General Purpose Reagent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-23
• Device Publish Date: 2020-09-15

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