Definition: In Vitro Diagnostic Test To Measure C-reactive Protein For The Purpose Of Making Cardiac Risk Assessments.
| Device Type ID | 3067 |
| Device Name | Cardiac C-reactive Protein, Antigen, Antiserum, And Control |
| Regulation Description | C-reactive Protein Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5270 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NQD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3067 |
| Device | Cardiac C-reactive Protein, Antigen, Antiserum, And Control |
| Product Code | NQD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | C-reactive Protein Immunological Test System. |
| CFR Regulation Number | 866.5270 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SENTINEL CH. SPA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect Or Inadequate Test Results | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Low Test Results | 1 |
Valve | 1 |
| Total Device Problems | 5 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Roche Diagnostics Operations, Inc. | II | Jan-24-2017 |
| 2 | Siemens Healthcare Diagnostics Inc | II | Jan-07-2016 |