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 |
Phone | 800.822.8824 |
techsupport@onelambda.com | |
Phone | 800.822.8824 |
techsupport@onelambda.com |
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 |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-08-11 |
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 |