Lymphotype HLA-AB 120 special

Basic Information

• Brand Name: Lymphotype HLA-AB 120 special
• Primary DI: 07611969952786
• Version / Model: 823031
• Catalog Number: 823031
• 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: 48308b98-e91b-4f29-95d5-6e7d92d9f143
• Distribution End Date: 2015-12-31

Device Description

for 3 detections of human HLA-AB 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
MZI	Test,Qualitative,For Hla,Non-Diagnostic	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
56321	HLA class I 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 I 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	07611969952786	GS1

Customer Contacts

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

Storage Conditions

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