Part 864 Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
FDA submissions for Part 864 Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products in the Hematology (HE) review panel, including product codes and regulations.
Section range: §§ 864.9050–864.9875
CFR Part: 864
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| KSS | Supplies, Blood-Bank | 864.9050 | 1 | 10 |
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | 864.9100 | 2 | 19 |
| QYC | Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions | 864.9115 | 2 | 1 |
| KST | System, Blood Collection, Vacuum-Assisted, Manual | 864.9125 | 1 | 0 |
| MYX | System, Blood Collection, Vacuum-Assisted, Automated | 864.9125 | 1 | 0 |
| KSW | System, Processing For Frozen Blood | 864.9145 | 2 | 1 |
| KSX | Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use | 864.9160 | 2 | 8 |
| MMH | Blood Establishment Computer Software And Accessories | 864.9165 | 2 | 20 |
| KSZ | System, Test, Automated Blood Grouping And Antibody | 864.9175 | 2 | 15 |
| OQX | Self-Contained Blood Grouping | 864.9175 | 2 | 0 |
| PBC | Manual Blood Grouping And Antibody Test Systems | 864.9175 | 2 | 0 |
| KSY | Boxes, View, Blood Grouping | 864.9185 | 1 | 1 |
| KSQ | Device, Blood Mixing And Blood Weighing | 864.9195 | 1 | 8 |
| MYJ | Device, Mixing And Weighing, Semi-Automated | 864.9195 | 2 | 0 |
| BSA | Warmer, Blood, Electromagnetic Radiation | 864.9205 | 3 | 0 |
| BSB | Warmer, Blood, Non-Electromagnetic Radiation | 864.9205 | 2 | 14 |
| KZL | Device, Warming. Blood And Plasma | 864.9205 | 2 | 4 |
| KSP | Apparatus, Cell-Freezing And Reagents | 864.9225 | 1 | 1 |
| GKT | Separator, Automated, Blood Cell, Diagnostic | 864.9245 | 2 | 17 |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | 864.9245 | 2 | 17 |
| PKG | Bone Marrow Processing Device To Support Hematopoietic Reconstitution | 864.9245 | 2 | 0 |
| PMQ | Peripheral Blood Processing Device For Wound Management | 864.9245 | 2 | 3 |
| KSO | Centrifuge, Blood-Bank For In Vitro Diagnostic Use | 864.9275 | 1 | 1 |
| KSN | Centrifuge, Cell-Washing, Automated For Immuno-Hematology | 864.9285 | 2 | 1 |
| KSM | System, Test, Combs, Automated | 864.9300 | 2 | 0 |
| KSL | Solution, Copper Sulfate For Specific Gravity Determinations | 864.9320 | 1 | 2 |
| KSK | Solution, Stabilized Enzyme | 864.9400 | 2 | 5 |
| KSI | Lectins And Protectins | 864.9550 | 2 | 4 |
| KSH | Chamber, Environmental For The Storage Of Platelet Concentrate | 864.9575 | 2 | 0 |
| KSG | Media, Potentiating For In Vitro Diagnostic Use | 864.9600 | 2 | 13 |
| KSF | Kit, Quality Control For Blood Banking Reagents | 864.9650 | 2 | 14 |
| PFK | Quality Control For Molecular Immunohematology Tests | 864.9650 | 2 | 0 |
| KSE | Refrigerator, Freezer, Blood Storage | 864.9700 | 2 | 4 |
| KSD | Device, Heat-Sealing | 864.9750 | 1 | 1 |
| KSB | Set, Transfer (Blood/Plasma) | 864.9875 | 2 | 6 |
