EtOH DA4015
GUDID 05055273208085
The ethanol assay is an in vitro diagnostic test for the quantitative analysis of ethanol in human urine and serum.
RANDOX LABORATORIES LIMITED
Ethanol (ETOH) IVD, reagent Ethanol (ETOH) IVD, reagent Ethanol (ETOH) IVD, reagent Ethanol (ETOH) IVD, reagent Ethanol (ETOH) IVD, reagent Ethanol (ETOH) IVD, reagent Ethanol (ETOH) IVD, reagent Ethanol (ETOH) IVD, reagent Ethanol (ETOH) IVD, reagent Ethanol (ETOH) IVD, reagent Ethanol (ETOH) IVD, reagent Ethanol (ETOH) IVD, reagent Ethanol (ETOH) IVD, reagent Ethanol (ETOH) IVD, reagent Ethanol (ETOH) IVD, reagent Ethanol (ETOH) IVD, reagent| 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 |
Customer Support Contacts
| 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 |
Operating and Storage Conditions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055273208085 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092273
FDA Product Code
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
Devices Manufactured by RANDOX LABORATORIES LIMITED
| 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 |
Trademark Results [EtOH]
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 |
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