Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1155](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1155) → LFS — Radioreceptor Assay, Human Chorionic Gonadotropin

# LFS · Radioreceptor Assay, Human Chorionic Gonadotropin

_Clinical Chemistry · 21 CFR 862.1155 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LFS

## Overview

- **Product Code:** LFS
- **Device Name:** Radioreceptor Assay, Human Chorionic Gonadotropin
- **Regulation:** [21 CFR 862.1155](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1155)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## Identification

A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.

## Classification Rationale

For early detection of pregnancy: Class II. For any uses other than early detection of pregnancy: Class III.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LFS](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LFS)

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