Pointe Scientific BUN Liquid
For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only.
1manufacturer
3catalogue 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 | Horiba Instruments Incorporated, United States |
|---|---|
| FDA product code | CDQ |
| Device type | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1770 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K972671 |
| Record published | 2016-08-31 |
| Record revised | 2025-10-02 (version 5) |
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 |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B7552-150 | In distribution | |
| B7552-450 | In distribution | |
| B7552-625 | 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 |
| 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
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.