Gamma PeG 0705003

GUDID 10888234001782

Gamma PeG is used an additive to enhance reactivity in the detection of unexpected blood group antibodies. This product is Polyethylene Glycol (PeG) i

IMMUCOR, INC.

Polyethylene glycol (PEG) immunohaematology reagent IVD

• Primary Device ID: 10888234001782
• NIH Device Record Key: 9a3a438a-38ac-4907-957b-8b18584054f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gamma PeG
• Version Model Number: 0705003
• Catalog Number: 0705003
• Company DUNS: 061446282
• Company Name: IMMUCOR, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-466-8267
• Email: tech_support@immucor.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234001782 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK910001

FDA Product Code

• KSG: Media, Potentiating For In Vitro Diagnostic Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-15

On-Brand Devices [Gamma PeG]

• 10888234001799: Gamma PeG is used an additive to enhance reactivity in the detection of unexpected blood group a
• 10888234001782: Gamma PeG is used an additive to enhance reactivity in the detection of unexpected blood group a