← Product Code [CEW](/productcode/CEW) · K871970

# DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2 (K871970)

_Diagnostic Products Corp. · CEW · Sep 25, 1987 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K871970

## Device Facts

- **Applicant:** Diagnostic Products Corp.
- **Product Code:** [CEW](/productcode/CEW.md)
- **Decision Date:** Sep 25, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1545
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/device/K871970](https://fda.innolitics.com/device/K871970)

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