| Primary Device ID | 05055273218725 |
| NIH Device Record Key | 93663247-6b61-41b1-b165-b4be1cdbc7ea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XANTHOCHROMIA POSITIVE CONTROL (XANTHOCHROMIA ) |
| Version Model Number | XN10505 |
| Company DUNS | 227530649 |
| Company Name | RANDOX LABORATORIES LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com |
| Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Humidity | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055273218725 [Primary] |
| OHQ | Multi-Analyte Controls Unassayed |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-29 |
| Device Publish Date | 2023-12-21 |
| 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 ) | 2023-12-29The Xanthochromia Positive Control is intended for use with in vitro diagnostic assays for the quantitative determination of Bilirubin and Oxyhaemoglobin for monitoring of Subarachnoid-haemorrhage testing in Cerebrospinal Fluid (CSF) for Xanthochromia using a spectrophotometer. Xanthochromia Positive Control is unassayed, without target values and is suitable for use on various UV spectrophotometer analysers. Xanthochromia Positive Control is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation. |
| 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 |