Gamma P1 Blood Group Substance 0007700

GUDID 10888234000846

Gamma P1 Blood Group Substance is intended for use in assistance in the identification of unexpected blood group antibodies by neutralizing anti-P1 ac

IMMUCOR, INC.

Immunoglobulin removal reagent IVD

• Primary Device ID: 10888234000846
• NIH Device Record Key: 9fa7d713-add6-4c04-8e5e-24423e67a08f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gamma P1 Blood Group Substance
• Version Model Number: 0007700
• Catalog Number: 0007700
• 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	10888234000846 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K802534

FDA Product Code

• KSX: Substance, Blood Grouping Of Non-Human Origin 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: 2016-04-19

Devices Manufactured by IMMUCOR, INC.

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