| Primary Device ID | 00812117010045 |
| NIH Device Record Key | a3140ed8-26b5-4ae2-bb2d-85396de5ee35 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Terasaki HLA-C Locus Tissue Typing Tray |
| Version Model Number | n/a |
| Catalog Number | C72 |
| 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 | 00812117010045 [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 |