Control-HLA (pos.)

Basic Information

• Brand Name: Control-HLA (pos.)
• Primary DI: 07611969953172
• Version / Model: 824101
• Catalog Number: 824101
• 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: 4
• Public Version Date: 2024-01-19
• Public Version Status: Update
• Public Device Record Key: be2fbedd-1888-4b79-b633-0b833269f936
• Distribution End Date: 2023-12-31

Device Description

For use in the microlymphocytotoxicity test

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
MZI	Test,Qualitative,For Hla,Non-Diagnostic	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
56400	HLA class I & II antigen tissue typing IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple HLA class I and II antigens in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07611969953172	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius