| Primary Device ID | 05055273208313 |
| NIH Device Record Key | 0f4a9295-d0d8-4206-baae-1bfb205d3226 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | D BIL |
| Version Model Number | BR8308 |
| Catalog Number | BR8308 |
| Company DUNS | 227530649 |
| Company Name | RANDOX LABORATORIES LIMITED |
| 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 | 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 | +442894451070 |
| technical.services@randox.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055273208313 [Primary] |
| JFM | Enzymatic Method, Bilirubin |
| 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 | 2016-09-16 |
| 05055273208320 | The device is intended for the quantitative in vitro determination of direct bilirubin in serum |
| 05055273208313 | The device is intended for the quantitative in vitro determination of direct bilirubin in serum |
| 05055273200836 | The device is intended for the quantitative in vitro determination of direct bilirubin in serum |
| 05055273200812 | The DBIL method used on the Dimension clinical chemistry system is an in vitro diagnostic test i |
| 05055273200799 | The device is intended for the quantitative in vitro determination of direct bilirubin in serum |