Architect
Urea Nitrogen
1manufacturer
2catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Abbott Laboratories, 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, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-09 |
| Record revised | 2018-04-17 (version 3) |
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; Handling environment temperature up to 29 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7D75-21 | In distribution | |
| 7D75-31 | 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 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 |
|---|---|
| K981918 | 1998-07-28 |
| K853677 | 1985-09-16 |
| K844755 | 1985-01-08 |
| K810794 | 1981-04-01 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-10-03 | Not classified | Process control | The reagents are being recalled due to particulate matter in some of the reagent cartridges. The particulate matter has been identified as Aureobasidium fungus species. | 5704 units of Urea Nitrogen | 2012-05-11 |
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.