Definition: An Immunoluminometric Assay Used To Determine The Concentration Of Procalcitonin (pct) In Human Serum And Plasma.
| Device Type ID | 3517 |
| Device Name | Antigen, Inflammatory Response Marker, Sepsis |
| Regulation Description | Endotoxin Assay. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3210 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NTM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3517 |
| Device | Antigen, Inflammatory Response Marker, Sepsis |
| Product Code | NTM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endotoxin Assay. |
| CFR Regulation Number | 866.3210 [🔎] |
| Device Problems | |
|---|---|
False Negative Result | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Healthcare Diagnostics, Inc | II | May-23-2014 |