| Primary Device ID | 05055273214529 |
| NIH Device Record Key | fc1355e4-9ce2-437f-a319-36e3b560996c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AWS |
| Version Model Number | WS8397 |
| Catalog Number | WS8397 |
| 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 | +44289445170 |
| technical.services@randox.com |
| Special Storage Condition, Specify | Between 0 and 0 *Once opened the reagent is stable for 1 month on board the analyser at approximately +10ºC |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055273214529 [Primary] |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| 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 |
| 05055273214529 | This product should be used in conjunction with RX daytona plus reagents to clean probes and cuv |
| 05055273206982 | This product should be used in conjunction with RX SERIES reagents to clean probes and cuvettes. |