Part 864 Subpart B—Biological Stains
FDA submissions for Part 864 Subpart B—Biological Stains in the Hematology (HE) review panel, including product codes and regulations.
Section range: §§ 864.1850–864.1870
CFR Part: 864
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| GGH | Iron Stains | 864.1850 | 1 | 1 |
| GHZ | Solution, Gugol Blue | 864.1850 | 1 | 0 |
| GJH | Stain, Reticulocyte | 864.1850 | 1 | 1 |
| GJJ | Stains, Heinz Body | 864.1850 | 1 | 0 |
| GJL | Romanowsky Stains | 864.1850 | 1 | 1 |
| HYB | Eosin Y | 864.1850 | 1 | 10 |
| HYC | Fast Green | 864.1850 | 1 | 1 |
| HYD | Fast Red Salt B | 864.1850 | 1 | 1 |
| HYE | Solution, Fontanna Silver | 864.1850 | 1 | 0 |
| HYF | Giemsa Stain | 864.1850 | 1 | 4 |
| HYG | Glenner'S Stain | 864.1850 | 1 | 1 |
| HYH | Gold Chloride | 864.1850 | 1 | 0 |
| HYI | Iodine, Grams | 864.1850 | 1 | 6 |
| HYJ | Hematoxylin | 864.1850 | 1 | 14 |
| HYK | Hematoxylin Harris'S | 864.1850 | 1 | 7 |
| HYL | Hematoxylin Mayer'S | 864.1850 | 1 | 0 |
| HYO | Hematoxylin Weigert'S | 864.1850 | 1 | 1 |
| HYQ | Iron Chloride-Weigert | 864.1850 | 1 | 0 |
| HYR | Leuco-Patent Blue | 864.1850 | 1 | 0 |
| HYS | Light Green | 864.1850 | 1 | 1 |
| HYT | Luxol Fast Blue | 864.1850 | 1 | 0 |
| HYW | Stain, Trichrome, Mallory'S | 864.1850 | 1 | 2 |
| HYY | Metanil Yellow | 864.1850 | 1 | 0 |
| HYZ | Methenamine Silver | 864.1850 | 1 | 0 |
| HZA | Methyl Green | 864.1850 | 1 | 2 |
| HZC | Mucicarmine | 864.1850 | 1 | 2 |
| HZD | Muller'S Colloidal Iron | 864.1850 | 1 | 0 |
| HZE | Nile Blue | 864.1850 | 1 | 0 |
| HZF | Nuclear Fast Red | 864.1850 | 1 | 0 |
| HZG | Oil Red O | 864.1850 | 1 | 1 |
| HZH | Orange G | 864.1850 | 1 | 4 |
| HZJ | Stain, Papanicolau | 864.1850 | 1 | 15 |
| HZL | Phloxine B | 864.1850 | 1 | 1 |
| HZM | Hematoxylin, Acid, Phosphotungstic | 864.1850 | 1 | 0 |
| HZN | Picro Methyl Blue | 864.1850 | 1 | 0 |
| HZO | Stain, Ponceau | 864.1850 | 1 | 1 |
| HZP | Pyronin | 864.1850 | 1 | 0 |
| HZQ | Red-Violet Lb | 864.1850 | 1 | 0 |
| HZR | Resorcin Fuchsin | 864.1850 | 1 | 0 |
| HZS | Safranin | 864.1850 | 1 | 1 |
| HZT | Reagent, Schiff | 864.1850 | 1 | 5 |
| HZX | Silver Nitrate | 864.1850 | 1 | 0 |
| HZY | Sirius Red | 864.1850 | 1 | 0 |
| HZZ | Sudan Black B | 864.1850 | 1 | 2 |
| IAA | Titan Yellow | 864.1850 | 1 | 0 |
| IAB | Toluidine Blue | 864.1850 | 1 | 1 |
| IAC | Van Gieson'S Stain | 864.1850 | 1 | 1 |
| IAD | Van Gieson'S Picro-Fuchsin | 864.1850 | 1 | 0 |
| IAE | Hematoxylin, Iron, Weigert'S | 864.1850 | 1 | 1 |
| IAF | Wright'S Stain | 864.1850 | 1 | 33 |
| ICC | Eosin B | 864.1850 | 1 | 1 |
| ICD | Darrow Red | 864.1850 | 1 | 0 |
| ICF | Crystal Violet For Histology | 864.1850 | 1 | 5 |
| ICG | Cresyl Violet Acetate | 864.1850 | 1 | 0 |
| ICH | Congo Red | 864.1850 | 1 | 1 |
| ICI | Hematoxylin, Chrome Alum | 864.1850 | 1 | 0 |
| ICJ | Carbol Night Blue | 864.1850 | 1 | 1 |
| ICL | Carbol Fuchsin | 864.1850 | 1 | 4 |
| ICM | Brilliant Yellow | 864.1850 | 1 | 0 |
| ICN | Biebrich Scarlet | 864.1850 | 1 | 2 |
| ICO | Best'S Carmine | 864.1850 | 1 | 0 |
| ICQ | Azure A | 864.1850 | 1 | 0 |
| ICR | Azocarmine B | 864.1850 | 1 | 0 |
| ICS | Azocarmine G | 864.1850 | 1 | 0 |
| ICT | Azan Counterstain | 864.1850 | 1 | 0 |
| ICX | Aniline | 864.1850 | 1 | 1 |
| ICY | Acid, Aniline, Fuchsin | 864.1850 | 1 | 0 |
| ICZ | Ammoniacal Silver Hydroxide Silver Nitrate | 864.1850 | 1 | 0 |
| IDA | Alcian Blue | 864.1850 | 1 | 2 |
| IDB | Aldehyde Fuchsin | 864.1850 | 1 | 0 |
| IDC | Acridine Orange | 864.1850 | 1 | 4 |
| IDD | Alizarin Red | 864.1850 | 1 | 0 |
| IDE | Acid, Hematein | 864.1850 | 1 | 0 |
| IDF | Acid, Fuchsin | 864.1850 | 1 | 1 |
| JCH | Esterase | 864.1850 | 1 | 0 |
| JCI | Acid Phosphatase, Cytochemical | 864.1850 | 1 | 0 |
| JTS | Stains, Microbiologic | 864.1850 | 1 | 40 |
| KFC | Methylene Blue, Tissue Stain | 864.1850 | 1 | 7 |
| KFD | Aniline Blue | 864.1850 | 1 | 1 |
| KFE | Neutral Red | 864.1850 | 1 | 1 |
| KJK | Auramine O | 864.1850 | 1 | 2 |
| KJL | Azure C | 864.1850 | 1 | 0 |
| KJM | Bismarck Brown Y | 864.1850 | 1 | 0 |
| KJN | Brilliant Cresyl Blue | 864.1850 | 1 | 1 |
| KJO | Brilliant Green | 864.1850 | 1 | 0 |
| KJP | Carmine | 864.1850 | 1 | 0 |
| KJQ | Chlorazol Black E | 864.1850 | 1 | 0 |
| KJR | Erythrosin B | 864.1850 | 1 | 3 |
| KJS | Ethyl Eosin | 864.1850 | 1 | 0 |
| KJT | Indigocarmine | 864.1850 | 1 | 0 |
| KJW | Janus Green B | 864.1850 | 1 | 0 |
| KJX | Jenner Stain | 864.1850 | 1 | 1 |
| KJY | Malachite Green | 864.1850 | 1 | 1 |
| KJZ | Martius Yellow | 864.1850 | 1 | 0 |
| KKA | Methyl Orange | 864.1850 | 1 | 0 |
| KKB | Methyl Violet 2b | 864.1850 | 1 | 0 |
| KKC | Methylene Violet | 864.1850 | 1 | 0 |
| KKD | Nigrosin | 864.1850 | 1 | 0 |
| KKE | Orange Ii | 864.1850 | 1 | 0 |
| KKF | Orcein | 864.1850 | 1 | 0 |
| KKG | Protargol S | 864.1850 | 1 | 0 |
| KKH | Tablet, Resazurin | 864.1850 | 1 | 0 |
| KKI | Rose Bengal | 864.1850 | 1 | 0 |
| KKJ | Sudan Iii | 864.1850 | 1 | 1 |
| KKK | Sudan Iv | 864.1850 | 1 | 1 |
| KKL | Thionin | 864.1850 | 1 | 0 |
| KKM | Methylene Blue Thiocyanate | 864.1850 | 1 | 0 |
| KKP | Solution, Silver Carbonate | 864.1850 | 1 | 0 |
| KKQ | Sodium Periodate | 864.1850 | 1 | 0 |
| KKR | Potassium Periodate | 864.1850 | 1 | 0 |
| KKS | Acid, Periodic | 864.1850 | 1 | 0 |
| KKT | Hematoxylin, Ehrlich'S | 864.1850 | 1 | 0 |
| KKW | Basic Fuchsin | 864.1850 | 1 | 0 |
| KQC | Stains, Hematology | 864.1850 | 1 | 9 |
| LED | Stains, Chemical Solution | 864.1850 | 1 | 16 |
| LEE | Stains, Dye Solution | 864.1850 | 1 | 1 |
| LEF | Stains, Dye Powder | 864.1850 | 1 | 1 |
| LGY | Trypan Blue | 864.1850 | 1 | 1 |
| LPI | Kit, Assay, Progesterone Receptor | 864.1860 | 3 | 4 |
| LPJ | Kit, Assay, Estrogen Receptor | 864.1860 | 3 | 4 |
| MXZ | Immunohistochemistry Assay, Antibody, Progesterone Receptor | 864.1860 | 2 | 13 |
| MYA | Immunohistochemistry Antibody Assay, Estrogen Receptor | 864.1860 | 2 | 12 |
| NBK | System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer | 864.1860 | 2 | 1 |
| NJT | Immunohistochemistry Reagents And Kits | 864.1860 | 1 | 0 |
| NJW | Control Material, Her-2/Neu, Immunohistochemistry | 864.1860 | 2 | 2 |
| NKF | Immunohistochemistry Antibody Assay, C-Kit | 864.1860 | 3 | 2 |
| NOT | Microscope, Automated, Image Analysis, Operator Intervention | 864.1860 | 2 | 12 |
| NQF | Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor | 864.1860 | 3 | 1 |
| NQN | Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity | 864.1860 | 2 | 15 |
| NTR | Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells | 864.1860 | 1 | 1 |
| OEO | Automated Digital Image Manual Interpretation Microscope | 864.1860 | 2 | 6 |
| QKF | Immunocytochemistry Assay, P16/Ki-67 | 864.1860 | 3 | 1 |
| QNH | Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay | 864.1860 | 3 | 3 |
| QUL | Immunohistochemistry Assay, Antibody, Folr1 | 864.1860 | 3 | 1 |
| QZJ | Immunohistochemistry Assay, Antibody, Claudin 18 | 864.1860 | 3 | 1 |
| SBL | Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4 | 864.1860 | 3 | 1 |
| SER | Immunohistochemistry Assay, Antibody, Met | 864.1860 | 3 | 1 |
| SDP | Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit | 864.1861 | 2 | 1 |
| PDO | Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization | 864.1870 | 2 | 1 |
| PFG | Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders | 864.1870 | 2 | 1 |
