RX daytona plus RX4040
GUDID 05055273207774
The Randox RX daytona plus with ISE is a fully automated, random access, clinical chemistry analyser complete with dedicated analyser software.
RANDOX LABORATORIES LIMITED
Multiple clinical chemistry analyser IVD, laboratory, automated| Primary Device ID | 05055273207774 |
| NIH Device Record Key | 34415135-8e31-4fd9-9276-c5ac62dbf179 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RX daytona plus |
| Version Model Number | RX4040 |
| Catalog Number | RX4040 |
| 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 | false |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055273207774 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K131554
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 | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-12-23 |
| Device Publish Date | 2018-06-07 |
On-Brand Devices [RX daytona plus]
| 05055273207781 | The Randox RX daytona plus without ISE is a fully automated, random access, clinical chemistry a |
| 05055273207774 | The Randox RX daytona plus with ISE is a fully automated, random access, clinical chemistry anal |
Trademark Results [RX daytona plus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RX DAYTONA PLUS 85762758 5019977 Live/Registered |
Randox Laboratories Ltd 2012-10-24 |
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