Specimen Diluent 403831

GUDID 10888234500445

For Use with LIFECODES B-Screen, Pak12, Pak12G, Pak2-LE, PakAuto, and PakPlus

IMMUCOR GTI DIAGNOSTICS, INC.

Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

• Primary Device ID: 10888234500445
• NIH Device Record Key: 67c7fff6-8579-4cdb-bec5-10b6a68a1751
• Commercial Distribution Discontinuation: 2018-08-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Specimen Diluent
• Version Model Number: 403831
• Catalog Number: 403831
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234500445 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK960059

FDA Product Code

• MYP: Test,Platelet Antibody

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: 2018-08-01
• Device Publish Date: 2016-07-08

On-Brand Devices [Specimen Diluent]

• 10888234500704: For Use with PakPlus100
• 10888234500445: For Use with LIFECODES B-Screen, Pak12, Pak12G, Pak2-LE, PakAuto, and PakPlus
• 10888234500353: For Use with PF4 Enhanced (X-HAT13 & X-HAT45) and PF4 IgG (HAT13G & HAT45G)