| Primary Device ID | 05055273202663 |
| NIH Device Record Key | 0bc9a48b-52b1-43d9-a92b-6d2d11705c15 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BUF WASH (conc.) |
| Version Model Number | EV3581 |
| Catalog Number | EV3581 |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The diluted wash solution is stable for 30 days in the absence of contamination when stored at (+2-8°C). |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The diluted wash solution is stable for 30 days in the absence of contamination when stored at (+2-8°C). |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The diluted wash solution is stable for 30 days in the absence of contamination when stored at (+2-8°C). |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The diluted wash solution is stable for 30 days in the absence of contamination when stored at (+2-8°C). |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The diluted wash solution is stable for 30 days in the absence of contamination when stored at (+2-8°C). |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The diluted wash solution is stable for 30 days in the absence of contamination when stored at (+2-8°C). |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The diluted wash solution is stable for 30 days in the absence of contamination when stored at (+2-8°C). |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The diluted wash solution is stable for 30 days in the absence of contamination when stored at (+2-8°C). |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The diluted wash solution is stable for 30 days in the absence of contamination when stored at (+2-8°C). |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The diluted wash solution is stable for 30 days in the absence of contamination when stored at (+2-8°C). |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The diluted wash solution is stable for 30 days in the absence of contamination when stored at (+2-8°C). |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The diluted wash solution is stable for 30 days in the absence of contamination when stored at (+2-8°C). |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The diluted wash solution is stable for 30 days in the absence of contamination when stored at (+2-8°C). |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The diluted wash solution is stable for 30 days in the absence of contamination when stored at (+2-8°C). |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The diluted wash solution is stable for 30 days in the absence of contamination when stored at (+2-8°C). |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055273202663 [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 |
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| 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 |
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