Dilution Solution 628515

GUDID 10888234400769

For Use with HLA-SSO Typing Kits

IMMUCOR GTI DIAGNOSTICS, INC.

DNA-based tissue typing IVD, kit, nucleic acid technique (NAT) Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD

• Primary Device ID: 10888234400769
• NIH Device Record Key: 671523b8-3f80-408c-a8a8-ad67e94f5f40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dilution Solution
• Version Model Number: 628515
• Catalog Number: 628515
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234400769 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK150302

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: 2016-09-15

On-Brand Devices [Dilution Solution]

• 10888234400769: For Use with HLA-SSO Typing Kits
• 10888234400745: For Use with HLA-SSO Typing Kits
• 10888234500827: For Use with HLA-SSO Typing Kits