KSS · Supplies, Blood-Bank
Hematology · 21 CFR 864.9050 · Class 1
Overview
| Product Code | KSS |
|---|---|
| Device Name | Supplies, Blood-Bank |
| Regulation | 21 CFR 864.9050 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
Blood bank supplies are general purpose devices intended for in vitro use in blood banking. This generic type of device includes products such as blood bank pipettes, blood grouping slides, blood typing tubes, blood typing racks, and cold packs for antisera reagents. The device does not include articles that are licensed by the Center for Biologics Evaluation and Research of the Food and Drug Administration.
Classification Rationale
Class I (general controls).
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| BK261315 | ELUclear Elution Kit | Hemo Bioscience, Inc. Durham, NC 27703 | May 29, 2026 | SESE |
| BK251272 | Alba Elution Kit | Alba Bioscience Limited United Kingdom | Nov 14, 2025 | SESE |
| BK251265 | ORTHO® Elution Kit | Alba Bioscience Limited United Kingdom | Nov 12, 2025 | SESE |
| BK231039 | Giotto Monza (BCS03) | Delcon S.r.l. Italy | Mar 26, 2025 | SESE |
| K874436 | FLUID SAMPLING PACK | U.S. Mfg. & Management, Inc. | Jan 5, 1988 | SESE |
| K812892 | S/P SERUM DROPPER PIPETS | American Dade | Oct 27, 1981 | SESE |
| K801516 | PRE-DENT SYSTEM MODIFIED | Pre-Dent System | Jul 14, 1980 | SESE |
| K801386 | PRE-DENT SYSTEM OR PRE-DENT II | Pre-Dent System | Jul 14, 1980 | SESE |
| K800736 | PRE-DENT SYSTEM | Pre-Dent System | Apr 24, 1980 | SESE |
| K761303 | IMMU-SAL IMMUNOHEMATOLOGICAL SALINE | Dade, Baxter Travenol Diagnostics, Inc. | Dec 30, 1976 | SESE |
Top Applicants
- Pre-Dent System — 3 clearances
- Alba Bioscience Limited United Kingdom — 2 clearances
- American Dade — 1 clearance
- Dade, Baxter Travenol Diagnostics, Inc. — 1 clearance
- Delcon S.r.l. Italy — 1 clearance
