| Primary Device ID | 00628055420088 |
| NIH Device Record Key | c0617d27-a770-4d77-bf27-7add29bf397e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spartan RX CYP2C19 System |
| Version Model Number | 01004872-ABC |
| Catalog Number | 01004872-ABC |
| Company DUNS | 243605917 |
| Company Name | Spartan Bioscience 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00628055420088 [Primary] |
| NSU | Instrumentation For Clinical Multiplex Test Systems |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-26 |
| 00628055420064 | This is Box 1 of 3 of the Spartan RX CYP2C19 Platform. It contains the Spartan RX Analyzer (0100 |
| 00628055420101 | A box of 20 SNP CYP2C19 External Control Kits. |
| 00628055420095 | A box of 10 CYP2C19 External Control Kits. |
| 00628055420088 | A box of 20 CYP2C19 Sample Collection Kits. |
| 00628055420071 | This is Box 2 of 3 for the Spartan RX CYP2C19 Platform. It contains the Spartan RX Netbook (0100 |
| 00628055420057 | The Spartan RX Sample Transport System supplied with the Spartan RX CYP2C19 System. It includes: |
| 00628055420040 | Barcode Scanner supplied with the Spartan RX CYP2C19 System. |
| 00628055420033 | Printer supplied with the Spartan RX CYP2C19 System |
| 00628055420026 | Netbook supplied with the Spartan RX CYP2C19 System. |
| 00628055420019 | Spartan RX Analyzer |