Evidence MultiSTAT EV4115
GUDID 05055273214970
The Evidence MultiSTAT is a benchtop, fully automated, immunoassay analyser that has been designed and developed to be operated in a wide range of laboratory settings within different industries. These include clinical, hospital, academic, research and development, veterinary and food laboratories.
RANDOX LABORATORIES LIMITED
Multiplex analyser IVD, laboratory| Primary Device ID | 05055273214970 |
| NIH Device Record Key | 0d00f40e-fe41-482d-8efa-2ad1d2111c8a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Evidence MultiSTAT |
| Version Model Number | EV4115 |
| Catalog Number | EV4115 |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | |
| Phone | +442894451070 |
| technical.services@randox.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 18 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 32 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055273214970 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K220451
FDA Product Code
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-23 |
| Device Publish Date | 2024-09-13 |
Devices Manufactured by RANDOX LABORATORIES LIMITED
| 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 | 2024-09-23The Evidence MultiSTAT is a benchtop, fully automated, immunoassay analyser that has been designed and developed to be operated in a wide range of laboratory settings within different industries. These include clinical, hospital, academic, research and development, veterinary and food laboratories. |
| 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 |
Trademark Results [Evidence MultiSTAT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EVIDENCE MULTISTAT 87808327 not registered Live/Pending |
Randox Laboratories Ltd 2018-02-23 |
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