| Primary Device ID | 07340035500162 |
| NIH Device Record Key | 5851f419-ebdb-49e5-acfc-6d691911b9bf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SSP DRB1*16 |
| Version Model Number | 101.126-12u |
| Company DUNS | 558836388 |
| Company Name | CareDx AB |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07340035500162 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-26 |
| Device Publish Date | 2023-07-18 |
| 07340035500025 - SSP DR Low | 2023-07-26 |
| 07340035500049 - SSP DR Low | 2023-07-26 |
| 07340035500087 - SSP DRB1*01 | 2023-07-26 |
| 07340035500100 - SSP DRB1*01 | 2023-07-26 |
| 07340035500124 - SSP DRB1*15 | 2023-07-26 |
| 07340035500148 - SSP DRB1*15 | 2023-07-26 |
| 07340035500162 - SSP DRB1*16 | 2023-07-26 |
| 07340035500162 - SSP DRB1*16 | 2023-07-26 |
| 07340035500186 - SSP DRB1*03 | 2023-07-26 |