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 |