Lymphotype HLA-DR/DQ 72

Basic Information

• Brand Name: Lymphotype HLA-DR/DQ 72
• Primary DI: 07611969952885
• Version / Model: 823102
• Catalog Number: 823102
• Company Name: Bio-Rad Medical Diagnostics GmbH
• Labeler DUNS: 312576506
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-01
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 68ed9fc3-21aa-42fc-8eb5-d42df31c5fff
• Distribution End Date: 2017-10-16

Device Description

for 6 detections of human HLA-DR/DQ antigens in the complement-dependent microlymphocytotoxicity test

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
GKZ	Counter, Differential Cell	Hematology	864.5220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56358	HLA class II antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple HLA class II antigens in a clinical specimen, using a complement-dependent cytotoxicity (CDC) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07611969952885	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – -20 Degrees Celsius