Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart J — Products Used In Establishments That Manufacture Blood and Blood Products](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products) → [21 CFR 864.9300](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9300) → KSM — System, Test, Combs, Automated

# KSM · System, Test, Combs, Automated

_Hematology · 21 CFR 864.9300 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSM

## Overview

- **Product Code:** KSM
- **Device Name:** System, Test, Combs, Automated
- **Regulation:** [21 CFR 864.9300](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9300)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

An automated Coombs test system is a device used to detect and identify antibodies in patient sera or antibodies bound to red cells. The Coombs test is used for the diagnosis of hemolytic disease of the newborn, and autoimmune hemolytic anemia. The test is also used in crossmatching and in investigating transfusion reactions and drug-induced red cell sensitization.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSM](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSM)

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