| Primary Device ID | 05714183000010 |
| NIH Device Record Key | e64b7eba-1dc7-4037-ad51-857d0fd266d1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dextramer CMV Kit |
| Version Model Number | CX02 |
| Catalog Number | CX02 |
| Company DUNS | 312388361 |
| Company Name | Immudex ApS |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1 703 766 4688 |
| customer@immudex.com |
| Special Storage Condition, Specify | Between 0 and 0 *2-8°C in the dark |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05714183000010 [Primary] |
| GKZ | Counter, Differential Cell |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-08 |
| Device Publish Date | 2018-10-08 |
| 05714183000126 - MHC Dextramer | 2023-12-18 Analyte specific reagent. Analytical and performance characteristics are not established. MHC Dextramer reagent recognizing T ce |
| 05714183000133 - MHC Dextramer | 2023-12-18 Analyte specific reagent. Analytical and performance characteristics are not established. MHC Dextramer reagent recognizing T ce |
| 05714183000010 - Dextramer CMV Kit | 2018-11-08The Dextramer® CMV Kit comprises :; HLA-A*0101 / VTEHDTLLY / PE; HLA-A*0201 / NLVPMVATV / PE; HLA-B*0702 / TPRVTGGGAM / PE; HLA-B*0801 / ELRRKMMYM / P |
| 05714183000010 - Dextramer CMV Kit | 2018-11-08 The Dextramer® CMV Kit comprises :; HLA-A*0101 / VTEHDTLLY / PE; HLA-A*0201 / NLVPMVATV / PE; HLA-B*0702 / TPRVTGGGAM / PE; HLA |