Part 864 Subpart I—Hematology Reagents
FDA submissions for Part 864 Subpart I—Hematology Reagents in the Hematology (HE) review panel, including product codes and regulations.
Section range: §§ 864.8100–864.8950
CFR Part: 864
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| JCO | Bothrops Atrox Reagent | 864.8100 | 2 | 7 |
| KRX | Calibrator For Cell Indices | 864.8150 | 2 | 16 |
| KRZ | Calibrator For Hemoglobin And Hematocrit Measurement | 864.8165 | 2 | 25 |
| KRY | Calibrator For Platelet Counting | 864.8175 | 2 | 8 |
| KSA | Calibrator For Red-Cell And White-Cell Counting | 864.8185 | 2 | 8 |
| GGJ | Fluid, Diluting, White-Cell | 864.8200 | 1 | 1 |
| GIF | Diluent, Blood Cell | 864.8200 | 1 | 38 |
| GJN | Fluid, Diluting, Red-Cell | 864.8200 | 1 | 0 |
| JCG | Fluid, Diluting, Manual Cell | 864.8200 | 1 | 1 |
| JCF | Lymphocyte Separation Medium | 864.8500 | 1 | 12 |
| GGK | Products, Red-Cell Lysing Products | 864.8540 | 1 | 29 |
| GFS | Standards And Controls, Hemoglobin, Normal And Abnormal | 864.8625 | 2 | 1 |
| GGL | Control, White-Cell | 864.8625 | 2 | 8 |
| GGM | Control, Hemoglobin | 864.8625 | 2 | 15 |
| GJP | Control, Platelet | 864.8625 | 2 | 4 |
| GJR | Control, Red-Cell | 864.8625 | 2 | 5 |
| GLK | Control, Hematocrit | 864.8625 | 2 | 7 |
| GLQ | Mixture, Control, White-Cell And Red-Cell Indices | 864.8625 | 2 | 10 |
| JCN | Control, Cell Counter, Normal And Abnormal | 864.8625 | 2 | 12 |
| JPK | Mixture, Hematology Quality Control | 864.8625 | 2 | 192 |
| MZG | Test, Residual, Wbc In Leukoreduced Blood | 864.8625 | 2 | 0 |
| NRF | Material, Quality Control, Semen Analysis | 864.8625 | 2 | 3 |
| NRS | Control Material, Blood Circulating Epithelial Cancer Cell | 864.8625 | 2 | 1 |
| GIR | Reagent, Russel Viper Venom | 864.8950 | 1 | 16 |
