| Primary Device ID | 05055273208054 |
| NIH Device Record Key | 478d9daf-46e6-4986-b138-53dad242a55e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPIAT |
| Version Model Number | DA4012 |
| Catalog Number | DA4012 |
| 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 *Stable on board analyser for 28 days at approx 10°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Stable on board analyser for 28 days at approx 10°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Stable on board analyser for 28 days at approx 10°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Stable on board analyser for 28 days at approx 10°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Stable on board analyser for 28 days at approx 10°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Stable on board analyser for 28 days at approx 10°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Stable on board analyser for 28 days at approx 10°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Stable on board analyser for 28 days at approx 10°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Stable on board analyser for 28 days at approx 10°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Stable on board analyser for 28 days at approx 10°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Stable on board analyser for 28 days at approx 10°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Stable on board analyser for 28 days at approx 10°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Stable on board analyser for 28 days at approx 10°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Stable on board analyser for 28 days at approx 10°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Stable on board analyser for 28 days at approx 10°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055273208054 [Primary] |
| DJG | Enzyme Immunoassay, Opiates |
| 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 |
| 05055273220018 - PlaySafe™ | 2024-10-09 The PlaySafe kit is intended for use in the collection of a urine sample for laboratory analysis of nine sexually transmitted in |
| 05055273216752 - Evidence MultiSTAT DOA Urine MultiPlex | 2024-09-24 The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyze |
| 05055273214970 - Evidence MultiSTAT | 2024-09-23 The Evidence MultiSTAT is a benchtop, fully automated, immunoassay analyser that has been designed and developed to be operated |
| 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 |