IDG/Sanzay
Urea nitrogen (BUN) liquid reagent is used for the kinetic quantitative determination of Urea Nitrogen (BUN) in human serum used in routine examination and monitoring of therapy and…
Urea nitrogen (BUN) liquid reagent is used for the kinetic quantitative determination of Urea Nitrogen (BUN) in human serum used in routine examination and monitoring of therapy and relapses.
1manufacturer
1catalogue number
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 | IDG/Sanzay Corporation |
|---|---|
| FDA product code | CDQ |
| Device type | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1770 |
| 510(k) | K981106 |
| Record published | 2024-01-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Sizes | Total volume 100 to 500 ml; total volume 1 l |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Total Volume 100 ml | 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.