| Primary Device ID | 05055273206937 |
| NIH Device Record Key | 10bafb7e-ea0b-4202-a08f-241a2a1ca5c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UREA |
| Version Model Number | UR456 |
| Catalog Number | UR456 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Once reconstituted it is stable for 4 weeks at +2 to +8°C or 2 days at +15 to +25°C. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055273206937 [Primary] |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| 05055273209600 | This product is intended for the quantitative in vitro determination of Urea in serum, plasma or |
| 05055273206975 | This product is intended for the quantitative in vitro determination of Urea in serum, plasma or |
| 05055273206968 | This product is intended for the quantitative in vitro determination of Urea in serum, plasma or |
| 05055273206951 | This product is intended for the quantitative in vitro determination of Urea in serum, plasma or |
| 05055273206944 | This product is intended for the quantitative in vitro determination of Urea in serum, plasma or |
| 05055273206937 | This product is intended for the quantitative in vitro determination of Urea in serum, plasma or |
| 05055273206920 | This product is intended for the quantitative in vitro determination of Urea in serum, plasma or |
| 05055273206913 | This product is intended for the quantitative in vitro determination of Urea in serum, plasma or |
| 05055273206906 | This product is intended for the quantitative in vitro determination of Urea in serum, plasma or |
| 05055273206869 | This product is intended for the quantitative in vitro determination of Urea in serum, plasma or |
| 05055273206852 | This product is intended for the quantitative in vitro determination of Urea in serum, plasma or |
| 05055273216172 | UR220 |