| Device Type ID | 252 |
| Device Name | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Regulation Description | Urea Nitrogen Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1770 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CDQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 252 |
| Device | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Product Code | CDQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urea Nitrogen Test System. |
| CFR Regulation Number | 862.1770 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Low Test Results | 221 |
High Test Results | 201 |
Mechanical Problem | 7 |
Incorrect Or Inadequate Test Results | 4 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Lamp | 1 |
Mixer | 1 |
Device Ingredient Or Reagent | 1 |
Insufficient Information | 1 |
Cell | 1 |
| Total Device Problems | 440 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Healthcare Diagnostics, Inc. | II | Jun-04-2018 |
| 2 | Siemens Healthcare Diagnostics, Inc. | II | May-06-2016 |