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 862.1675](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1675) → QZG — Menstrual Blood Collection Device

# QZG · Menstrual Blood Collection Device

_Clinical Chemistry · 21 CFR 862.1675 · Class 2_

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

## Overview

- **Product Code:** QZG
- **Device Name:** Menstrual Blood Collection Device
- **Regulation:** [21 CFR 862.1675](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1675)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

## Classification Rationale

Class II.

## 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/QZG](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/QZG)

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