Concentrated Wash (10X) 404563

GUDID 10888234500483

For Use with DonorScreen-HLA Class I and Class II

IMMUCOR GTI DIAGNOSTICS, INC.

HLA class I & II antibody screening IVD, reagent HLA class I & II antibody screening IVD, reagent HLA class I & II antibody screening IVD, reagent HLA class I & II antibody screening IVD, reagent HLA class I & II antibody screening IVD, reagent HLA class I & II antibody screening IVD, reagent HLA class I & II antibody screening IVD, reagent HLA class I & II antibody screening IVD, reagent HLA class I & II antibody screening IVD, reagent HLA class I & II antibody screening IVD, reagent HLA class I & II antibody screening IVD, reagent HLA class I & II antibody screening IVD, reagent HLA class I & II antibody screening IVD, reagent HLA class I & II antibody screening IVD, reagent HLA class I & II antibody screening IVD, reagent HLA class I & II antibody screening IVD, reagent HLA class I & II antibody screening IVD, reagent

• Primary Device ID: 10888234500483
• NIH Device Record Key: a143d8cd-dfcc-45d2-a76a-215096f0b813
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Concentrated Wash (10X)
• Version Model Number: 404563
• Catalog Number: 404563
• Company DUNS: 606034197
• Company Name: IMMUCOR GTI DIAGNOSTICS, 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.co
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234500483 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK070045

FDA Product Code

• MZI: Test,Qualitative,For Hla,Non-Diagnostic

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: 2016-07-08

On-Brand Devices [Concentrated Wash (10X)]

• 10888234500681: For Use with PakPlus100
• 10888234500483: For Use with DonorScreen-HLA Class I and Class II
• 10888234500407: For Use with Factor VIII Antibody Screen, LIFECODES B-Screen, LIFECODES QuikScreen, Pak12, Pak12