Terasaki HLA-C Locus Tissue Typing Tray C722

GUDID 00812117010090

HLA class I & II antigen tissue typing IVD, kit, multiplex

Primary Device ID	00812117010090
NIH Device Record Key	282154a1-6cbd-4a5f-83d2-baced8046a0c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Terasaki HLA-C Locus Tissue Typing Tray
Version Model Number	n/a
Catalog Number	C722
Company DUNS	118289289
Company Name	ONE LAMBDA, 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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
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

Storage Environment Temperature	Between -65 Degrees Celsius and 0 Degrees Celsius
Storage Environment Temperature	Between -65 Degrees Celsius and 0 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00812117010090 [Primary]

MZI	Test,Qualitative,For Hla,Non-Diagnostic

Steralize Prior To Use	false
Device Is Sterile	false

00812117010090	For use in determining HLA Class I and Class II cell surface antigens with a complement dependen
00812117010045	For use in determining HLA Class I and Class II cell surface antigens with a complement dependen