Definition: An In Vitro Diagnostic Device Intended As An Aid In The Clinical Diagnosis Of Patients With A Suspicion Of Systemic Mastocytosis In Conjunction With Other Clinical And Laboratory Findings.
| Device Type ID | 3092 |
| Device Name | Tryptase Assay System |
| Physical State | N/a |
| Technical Method | Immunoassay |
| Target Area | Plasma And Serum Samples |
| Regulation Description | Tryptase 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 | 866.5760 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OYL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3092 |
| Device | Tryptase Assay System |
| Product Code | OYL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tryptase Test System. |
| CFR Regulation Number | 866.5760 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PHADIA AB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |