| Primary Device ID | 00860012318230 |
| NIH Device Record Key | 5c3eee28-f5f3-4ec3-a965-a40a9e469e37 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Xpeedy |
| Version Model Number | DOA20 |
| Company DUNS | 119132639 |
| Company Name | Cura Diagnostics Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 00860012318230 [Primary] |
| JJH | Clinical Sample Concentrator |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-29 |
| Device Publish Date | 2024-07-19 |
| 00860012318230 | The Xpeedy DOA20 Automated Sample Preparation for Triple Quadrupole LC/MS/MS Analysis is used fo |
| 10860012318220 | Xpeedy Urine Collection Cup - 90mL, with Vaccum Lid, Sterile |
| 10860012318213 | Xpeedy Vaccum Urine Collection Tube 16 mm x 100 mm, Yellow Cap |
| 10860012318206 | Xpeedy Vaccum Urine Collection Tube 13 mm x 100 mm, White Cap |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() XPEEDY 97902497 not registered Live/Pending |
Cura Diagnostics Inc. 2023-04-23 |