Primary Device ID | 05055273208085 |
NIH Device Record Key | ad788882-4417-4b18-8d3e-bcc62a35df37 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EtOH |
Version Model Number | DA4015 |
Catalog Number | DA4015 |
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 | |
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 |
Special Storage Condition, Specify | Between 0 and 0 *Avoid prolonged exposure of the reagent at temperatures higher than +25ºC |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Avoid prolonged exposure of the reagent at temperatures higher than +25ºC |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Avoid prolonged exposure of the reagent at temperatures higher than +25ºC |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Avoid prolonged exposure of the reagent at temperatures higher than +25ºC |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Avoid prolonged exposure of the reagent at temperatures higher than +25ºC |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Avoid prolonged exposure of the reagent at temperatures higher than +25ºC |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Avoid prolonged exposure of the reagent at temperatures higher than +25ºC |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Avoid prolonged exposure of the reagent at temperatures higher than +25ºC |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Avoid prolonged exposure of the reagent at temperatures higher than +25ºC |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Avoid prolonged exposure of the reagent at temperatures higher than +25ºC |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Avoid prolonged exposure of the reagent at temperatures higher than +25ºC |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Avoid prolonged exposure of the reagent at temperatures higher than +25ºC |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Avoid prolonged exposure of the reagent at temperatures higher than +25ºC |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Avoid prolonged exposure of the reagent at temperatures higher than +25ºC |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Avoid prolonged exposure of the reagent at temperatures higher than +25ºC |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05055273208085 [Primary] |
DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method |
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 | 2016-09-24 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ETOH 88024332 5860062 Live/Registered |
ExtractCraft, LLC 2018-07-03 |
![]() ETOH 85593006 not registered Dead/Abandoned |
Collett,John M 2012-04-09 |
![]() ETOH 78043359 not registered Dead/Abandoned |
Strategic Light Inc. 2001-01-16 |