| Primary Device ID | 05055273204704 |
| NIH Device Record Key | f85f5f7b-78e1-400d-ba58-9a56011fbd13 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Na |
| Version Model Number | NA7167 |
| Catalog Number | NA7167 |
| 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 *R1 Stable for 2 weeks at +2 to +8°C or 5 days at +15 to +25°C once opened. R2 Stable for 4 weeks at +2 to +8°C or 2 weeks at +15 to +25°C omce opened. CAL Stable when stored at 2-25°C |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055273204704 [Primary] |
| CEI | Uranyl Acetate/Zinc Acetate, Sodium |
| 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 |
| 05055273209310 | This product is intended for the quantitative in vitro determination of Sodium in serum |
| 05055273204704 | This product is intended for the quantitative in vitro determination of Sodium in serum and plas |
| 05055273204698 | This product is intended for the quantitative in vitro determination of Sodium in serum and plas |