KSZ · System, Test, Automated Blood Grouping And Antibody
Hematology · 21 CFR 864.9175 · Class 2
Overview
| Product Code | KSZ |
|---|---|
| Device Name | System, Test, Automated Blood Grouping And Antibody |
| Regulation | 21 CFR 864.9175 |
| Device Class | Class 2 |
| Review Panel | Hematology |
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 | Erytra Eflexis | Diagnostic Grifols S.A. Barcelona, 08150, Spain | May 21, 2026 | SESE |
| BK261331 | ORTHO Optix™ Reader | Ortho-Clinical Diagnostics, Inc. Raritan, NJ 08869 | May 13, 2026 | SESE |
| BK251238 | ORTHO VISION® Analyzer and ORTHO VISION® Max Analyzer | Ortho-Clinical Diagnostics, Inc. | Oct 10, 2025 | SESE |
| BK251184 | DG Gel 8 Neutral card | Diagnostic Grifols, S.A. Barcelona, Spain | Jun 17, 2025 | SESE |
| BK251183 | Erytra | Diagnostic Grifols, S.A. Barcelona, Spain | Jun 17, 2025 | SESE |
| BK251182 | Erytra Eflexis | Diagnostic Grifols, S.A. Barcelona, Spain | Jun 17, 2025 | SESE |
| BK210608 | Galileo Echo | Immucor, Inc. Norcross, GA | Jan 8, 2025 | SESE |
| BK210604 | Complement Control Cells | Immucor, Inc. Norcross, GA | Jan 8, 2025 | SESE |
| BK210601 | Echo Lumena | Immucor, Inc. Norcross, GA | Jan 8, 2025 | SESE |
| BK230971 | IH-500 | Bio-Rad Medical Diagnostics GmbH Redmond, WA | Aug 9, 2023 | SESE |
| BK230820 | Erytra Eflexis | Diagnostic Grifols, S.A. Barcelona, Spain | Jun 22, 2023 | SESE |
| K810899 | TECHNICON AUTOGROUPER 16-C SYSTEM | Technicon Instruments Corp. | May 5, 1981 | SESE |
| K790282 | ELDONCARD | Nordisk Infuser System | May 4, 1979 | SESE |
| K771098 | BLOOD GROUPING SYS., BG-9 | Technicon Instruments Corp. | Aug 4, 1977 | SESE |
| K770185 | 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
