PakPlus® PAKPLUS100

GUDID 10888234500674

The PakPlus assay is a qualitative solid-phase enzyme-linked immunosorbent assay (ELISA) designed to screen for antibodies to HLA Class I and platelet

IMMUCOR GTI DIAGNOSTICS, INC.

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

• Primary Device ID: 10888234500674
• NIH Device Record Key: f81ee971-391b-4415-bad7-5f9f7b998b65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PakPlus®
• Version Model Number: PAKPLUS100
• Catalog Number: PAKPLUS100
• 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: true
• 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: waukeshatechsupport@immucor.co
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com
• Phone: 855-466-8267
• Email: waukeshatechsupport@immucor.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234500674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK140163

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-01

On-Brand Devices [PakPlus®]

• 10888234500674: The PakPlus assay is a qualitative solid-phase enzyme-linked immunosorbent assay (ELISA) designe
• 10888234500254: The PakPlus assay is a qualitative solid-phase enzyme-linked immunosorbent assay (ELISA) designe