| Primary Device ID | 15051716000022 |
| NIH Device Record Key | 60c1d520-5387-412e-bb88-35aea82359e0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | T.Cell Xtend® |
| Version Model Number | TTK.610 |
| Catalog Number | TTK.610US |
| Company DUNS | 009744265 |
| Company Name | Oxford Immunotec, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15051716000022 [Primary] |
| OJN | Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-08-12 |
| 15051716000053 | Approval for the use of t-cell xtend reagent with the t-spot. Tb test, in order to extend the ti |
| 15051716000022 | Approval for the use of t-cell xtend reagent with the t-spot. Tb test, in order to extend the ti |