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 864.9175](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9175) → KSZ — System, Test, Automated Blood Grouping And Antibody

# KSZ · System, Test, Automated Blood Grouping And Antibody

_Hematology · 21 CFR 864.9175 · Class 2_

**Canonical URL:** https://fda-staging.innolitics.com/productcode/KSZ

## Overview

- **Product Code:** KSZ
- **Device Name:** System, Test, Automated Blood Grouping And Antibody
- **Regulation:** [21 CFR 864.9175](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9175)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

An automated blood grouping and antibody test system is a device used to group erythrocytes (red blood cells) and to detect antibodies to blood group antigens.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (15 of 15)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [BK261329](/device/BK261329.md) | Erytra Eflexis | Diagnostic Grifols S.A. Barcelona, 08150, Spain | May 21, 2026 | SESE |
| [BK261331](/device/BK261331.md) | ORTHO Optix™ Reader | Ortho-Clinical Diagnostics, Inc. Raritan, NJ 08869 | May 13, 2026 | SESE |
| [BK251238](/device/BK251238.md) | ORTHO VISION® Analyzer and ORTHO VISION® Max Analyzer | Ortho-Clinical Diagnostics, Inc. | Oct 10, 2025 | SESE |
| [BK251184](/device/BK251184.md) | DG Gel 8 Neutral card | Diagnostic Grifols, S.A. Barcelona, Spain | Jun 17, 2025 | SESE |
| [BK251183](/device/BK251183.md) | Erytra | Diagnostic Grifols, S.A. Barcelona, Spain | Jun 17, 2025 | SESE |
| [BK251182](/device/BK251182.md) | Erytra Eflexis | Diagnostic Grifols, S.A. Barcelona, Spain | Jun 17, 2025 | SESE |
| [BK210608](/device/BK210608.md) | Galileo Echo | Immucor, Inc. Norcross, GA | Jan 8, 2025 | SESE |
| [BK210604](/device/BK210604.md) | Complement Control Cells | Immucor, Inc. Norcross, GA | Jan 8, 2025 | SESE |
| [BK210601](/device/BK210601.md) | Echo Lumena | Immucor, Inc. Norcross, GA | Jan 8, 2025 | SESE |
| [BK230971](/device/BK230971.md) | IH-500 | Bio-Rad Medical Diagnostics GmbH Redmond, WA | Aug 9, 2023 | SESE |
| [BK230820](/device/BK230820.md) | Erytra Eflexis | Diagnostic Grifols, S.A. Barcelona, Spain | Jun 22, 2023 | SESE |
| [K810899](/device/K810899.md) | TECHNICON AUTOGROUPER 16-C SYSTEM | Technicon Instruments Corp. | May 5, 1981 | SESE |
| [K790282](/device/K790282.md) | ELDONCARD | Nordisk Infuser System | May 4, 1979 | SESE |
| [K771098](/device/K771098.md) | BLOOD GROUPING SYS., BG-9 | Technicon Instruments Corp. | Aug 4, 1977 | SESE |
| [K770185](/device/K770185.md) | RH CONTROL DILUENT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Mar 14, 1977 | SESE |

## Top Applicants

- Diagnostic Grifols, S.A. Barcelona, Spain — 4 clearances
- Immucor, Inc. Norcross, GA — 3 clearances
- Technicon Instruments Corp. — 2 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Bio-Rad Medical Diagnostics GmbH Redmond, WA — 1 clearance

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**Source:** [https://fda-staging.innolitics.com/productcode/KSZ](https://fda-staging.innolitics.com/productcode/KSZ)

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