INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)
Device Facts
| Record ID | K954418 |
|---|---|
| Device Name | INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION) |
| Applicant | Nichols Institute Diagnostics |
| Product Code | CEW · Clinical Chemistry |
| Decision Date | Nov 3, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1545 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.
