Gamma N-HANCE 0705410

GUDID 10888234001812

Gamma N-HANCE is used an additive to enhance reactivity in the detection of unexpected blood group antibodies. This product is Low Ionic Strength Sali

IMMUCOR, INC.

Low ionic-strength salt solution (LISS) immunohaematology reagent IVD Low ionic-strength salt solution (LISS) immunohaematology reagent IVD Low ionic-strength salt solution (LISS) immunohaematology reagent IVD Low ionic-strength salt solution (LISS) immunohaematology reagent IVD Low ionic-strength salt solution (LISS) immunohaematology reagent IVD Low ionic-strength salt solution (LISS) immunohaematology reagent IVD Low ionic-strength salt solution (LISS) immunohaematology reagent IVD Low ionic-strength salt solution (LISS) immunohaematology reagent IVD Low ionic-strength salt solution (LISS) immunohaematology reagent IVD Low ionic-strength salt solution (LISS) immunohaematology reagent IVD

• Primary Device ID: 10888234001812
• NIH Device Record Key: 94b866cd-bda5-47ad-9d81-2a0a2b0fae7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gamma N-HANCE
• Version Model Number: 0705410
• Catalog Number: 0705410
• 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
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• 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
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234001812 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK860024

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: 4
• Public Version Date: 2018-09-12
• Device Publish Date: 2016-04-15

On-Brand Devices [Gamma N-HANCE]

• 10888234001812: Gamma N-HANCE is used an additive to enhance reactivity in the detection of unexpected blood gro
• 10888234001805: Gamma N-HANCE is used an additive to enhance reactivity in the detection of unexpected blood gro