UREA-L3K
2 catalogue numbers from 283-99, listed by Sekisui Diagnostics, LLC, United States, under Urease And Glutamic Dehydrogenase, Urea Nitrogen. 1 manufacturer in China is registered for this product code.
1manufacturer
2catalogue numbers in this listing
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 | Sekisui Diagnostics, LLC, United States |
|---|---|
| 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, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K002694 |
| Record published | 2016-09-16 |
| Record revised | 2026-06-30 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 283-99 | In distribution | ||
| 283-30 | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| JAS Diagnostics | Drew Scientific, Ltd. | 12 |
| Urea | Randox Laboratories Limited | 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 |
Showing 12 of 49. All products under Urease And Glutamic Dehydrogenase, Urea Nitrogen
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.