| Primary Device ID | 05055273202656 |
| NIH Device Record Key | 869c4687-6b49-421f-b056-37402242535c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DISP FL (conc.) |
| Version Model Number | EV3580 |
| Catalog Number | EV3580 |
| 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 | |
| Phone | +44289445170 |
| technical.services@randox.com | |
| Phone | +44289445170 |
| technical.services@randox.com | |
| Phone | +44289445170 |
| technical.services@randox.com | |
| Phone | +44289445170 |
| technical.services@randox.com | |
| Phone | +44289445170 |
| technical.services@randox.com | |
| Phone | +44289445170 |
| technical.services@randox.com | |
| Phone | +44289445170 |
| technical.services@randox.com | |
| Phone | +44289445170 |
| technical.services@randox.com | |
| Phone | +44289445170 |
| technical.services@randox.com | |
| Phone | +44289445170 |
| technical.services@randox.com | |
| Phone | +44289445170 |
| technical.services@randox.com | |
| Phone | +44289445170 |
| technical.services@randox.com | |
| Phone | +44289445170 |
| technical.services@randox.com | |
| Phone | +44289445170 |
| technical.services@randox.com | |
| Phone | +44289445170 |
| technical.services@randox.com |
| Special Storage Condition, Specify | Between 0 and 0 *The working solution is stable onboard the Evidence™ analyser at room temperature for 48 hours. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The working solution is stable onboard the Evidence™ analyser at room temperature for 48 hours. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The working solution is stable onboard the Evidence™ analyser at room temperature for 48 hours. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The working solution is stable onboard the Evidence™ analyser at room temperature for 48 hours. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The working solution is stable onboard the Evidence™ analyser at room temperature for 48 hours. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The working solution is stable onboard the Evidence™ analyser at room temperature for 48 hours. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The working solution is stable onboard the Evidence™ analyser at room temperature for 48 hours. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The working solution is stable onboard the Evidence™ analyser at room temperature for 48 hours. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The working solution is stable onboard the Evidence™ analyser at room temperature for 48 hours. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The working solution is stable onboard the Evidence™ analyser at room temperature for 48 hours. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The working solution is stable onboard the Evidence™ analyser at room temperature for 48 hours. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The working solution is stable onboard the Evidence™ analyser at room temperature for 48 hours. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The working solution is stable onboard the Evidence™ analyser at room temperature for 48 hours. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The working solution is stable onboard the Evidence™ analyser at room temperature for 48 hours. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The working solution is stable onboard the Evidence™ analyser at room temperature for 48 hours. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055273202656 [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 | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-26 |
| 05055273219951 - ESSENTIAL PACKAGE SAMPLE COLLECTION KIT (USA) | 2024-02-07 The Blood Sample Collection Kit is intended for use in the collection and transport of a blood sample, taken by a trained phlebo |
| 05055273219968 - EXTENDED PACKAGE SAMPLE COLLECTION KIT (USA) | 2024-02-07 The Blood Sample Collection Kit is intended for use in the collection and transport of a blood sample, taken by a trained phlebo |
| 05055273219999 - EXTENDED PACKAGE SAMPLE COLLECTION KIT (USA U60) | 2024-02-07 The Blood Sample Collection Kit is intended for use in the collection and transport of a blood sample, taken by a trained phlebo |
| 05055273218480 - BNP CONTROLS FOR BECKMAN (BNP CONTROL) | 2023-12-29 The BNP Controls for Beckman (CQ10520) are intended for use with in vitro diagnostic assays for the quantitative determination o |
| 05055273218497 - BNP CONTROLS FOR ABBOTT (BNP CONTROL) | 2023-12-29 The BNP Controls for Abbott (CQ10521) are intended for use with in vitro diagnostic assays for the quantitative determination of |
| 05055273218725 - XANTHOCHROMIA POSITIVE CONTROL (XANTHOCHROMIA ) | 2023-12-29 The Xanthochromia Positive Control is intended for use with in vitro diagnostic assays for the quantitative determination of Bil |
| 05055273218732 - XANTHOCHROMIA NEGATIVE CONTROL (XANTHOCHROMIA ) | 2023-12-29 The Xanthochromia Negative Control is intended for use with in vitro diagnostic assays for the quantitative determination of Bil |
| 05055273218992 - PRE-ECLAMPSIA CONTROL LEVEL 3 | 2023-12-29 The Pre eclampsia Control Level 3 is intended for use with in vitro diagnostic assays for the quantitative determination of plac |