Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart A](/submissions/HE/subpart-a%E2%80%94) → [21 CFR 660.20](/submissions/HE/subpart-a%E2%80%94/660.20) → QHR — Blood Grouping Reagent

# QHR · Blood Grouping Reagent

_Hematology · 21 CFR 660.20 · Class U_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-a%E2%80%94/QHR

## Overview

- **Product Code:** QHR
- **Device Name:** Blood Grouping Reagent
- **Regulation:** [21 CFR 660.20](/submissions/HE/subpart-a%E2%80%94/660.20)
- **Device Class:** U
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

The proper name of this product shall be Blood Grouping Reagent and it shall consist of an antibody-containing fluid containing one or more of the blood grouping antibodies listed in § 660.28(a)(4). The source of this product shall be blood, plasma, serum, or protein-rich fluids, such as those derived from stable immunoglobulin-secreting cell lines maintained either in tissue cultures or in secondary hosts.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-a%E2%80%94/QHR](https://fda.innolitics.com/submissions/HE/subpart-a%E2%80%94/QHR)

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