Concentrated Wash (10X)

Basic Information

• Brand Name: Concentrated Wash (10X)
• Primary DI: 10888234500407
• Version / Model: 403622
• Catalog Number: 403622
• Company Name: IMMUCOR GTI DIAGNOSTICS, INC.
• Labeler DUNS: 606034197
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-08
• Public Version: 4
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: 83bccd0b-f681-4a9e-8c13-74b5ff3c743e

Device Description

For Use with Factor VIII Antibody Screen and PakPlus

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MYP	Test,Platelet Antibody	Unknown		2

GMDN Terms

Code	Name	Definition	Implantable	Status
56531	HLA class I antibody screening IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used in screening for one or multiple antibodies to HLA class I antigens in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888234500407	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
BK960059	0

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius