Urea
This product is intended for the quantitative in vitro determination of Urea in serum, plasma or urine.
1manufacturer
12catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
Record
| Listed by | Randox Laboratories Limited, United Kingdom |
|---|---|
| FDA product code | CDQ |
| Device type | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1770 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K923506 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C; Special storage condition: Once reconstituted it is stable for 4 weeks at +2 to +8°C or 2 days at +15 to +25°C. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UR221 | In distribution | |
| UR8334 | In distribution | |
| UR3873 | In distribution | |
| UR9729 | In distribution | |
| UR220 | In distribution | |
| UR446 | In distribution | |
| UR456 | In distribution | |
| UR220 | In distribution | |
| UR457 | In distribution | |
| UR3825 | In distribution | |
| UR7976 | In distribution | |
| UR7975 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| JAS Diagnostics | Drew Scientific, Ltd. | 12 |
| Synermed® | Infrared Laboratory Systems LLC | 8 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 6 |
| AU | Beckman Coulter, Inc. | 6 |
| UreaBUN | Roche Diagnostics Gmbh | 3 |
| Kinetic UV assay for ureaurea nitrogen | Roche Diagnostics Gmbh | 3 |
| Pointe Scientific BUN Liquid | Horiba Instruments Incorporated | 3 |
| Alinity | Abbott Medical | 2 |
| Architect | Abbott Laboratories | 2 |
| Architect | Abbott Medical | 2 |
| Urea Nitrogen (BUN) Liqui-UV® | Stanbio Laboratory, L.P. | 2 |
| UREA-L3K | Sekisui Diagnostics, LLC | 2 |
Showing 12 of 49. All products under Urease And Glutamic Dehydrogenase, Urea Nitrogen
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K923506 | 1993-09-27 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Randox Laboratories Limited | 510(k) number | 2023-06-13 | Class II | Under Investigation by firm | Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after the Direct LDL-choles | 37 US 194 PR |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.