21 CFR 864.1850 — Iron Stains
Hematology (HE) · Part 864 Subpart B—Biological Stains · § 864.1850
Identification
Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.
Classification Rationale
Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GGH | Iron Stains | 1 | 1 | |
| GHZ | Solution, Gugol Blue | 1 | 0 | |
| GJH | Stain, Reticulocyte | 1 | 1 | |
| GJJ | Stains, Heinz Body | 1 | 0 | |
| GJL | Romanowsky Stains | 1 | 1 | |
| HYB | Eosin Y | 1 | 10 | |
| HYC | Fast Green | 1 | 1 | |
| HYD | Fast Red Salt B | 1 | 1 | |
| HYE | Solution, Fontanna Silver | 1 | 0 | |
| HYF | Giemsa Stain | 1 | 4 | |
| HYG | Glenner'S Stain | 1 | 1 | |
| HYH | Gold Chloride | 1 | 0 | |
| HYI | Iodine, Grams | 1 | 6 | |
| HYJ | Hematoxylin | 1 | 14 | |
| HYK | Hematoxylin Harris'S | 1 | 7 | |
| HYL | Hematoxylin Mayer'S | 1 | 0 | |
| HYO | Hematoxylin Weigert'S | 1 | 1 | |
| HYQ | Iron Chloride-Weigert | 1 | 0 | |
| HYR | Leuco-Patent Blue | 1 | 0 | |
| HYS | Light Green | 1 | 1 | |
| HYT | Luxol Fast Blue | 1 | 0 | |
| HYW | Stain, Trichrome, Mallory'S | 1 | 2 | |
| HYY | Metanil Yellow | 1 | 0 | |
| HYZ | Methenamine Silver | 1 | 0 | |
| HZA | Methyl Green | 1 | 2 | |
| HZC | Mucicarmine | 1 | 2 | |
| HZD | Muller'S Colloidal Iron | 1 | 0 | |
| HZE | Nile Blue | 1 | 0 | |
| HZF | Nuclear Fast Red | 1 | 0 | |
| HZG | Oil Red O | 1 | 1 | |
| HZH | Orange G | 1 | 4 | |
| HZJ | Stain, Papanicolau | 1 | 15 | |
| HZL | Phloxine B | 1 | 1 | |
| HZM | Hematoxylin, Acid, Phosphotungstic | 1 | 0 | |
| HZN | Picro Methyl Blue | 1 | 0 | |
| HZO | Stain, Ponceau | 1 | 1 | |
| HZP | Pyronin | 1 | 0 | |
| HZQ | Red-Violet Lb | 1 | 0 | |
| HZR | Resorcin Fuchsin | 1 | 0 | |
| HZS | Safranin | 1 | 1 | |
| HZT | Reagent, Schiff | 1 | 5 | |
| HZX | Silver Nitrate | 1 | 0 | |
| HZY | Sirius Red | 1 | 0 | |
| HZZ | Sudan Black B | 1 | 2 | |
| IAA | Titan Yellow | 1 | 0 | |
| IAB | Toluidine Blue | 1 | 1 | |
| IAC | Van Gieson'S Stain | 1 | 1 | |
| IAD | Van Gieson'S Picro-Fuchsin | 1 | 0 | |
| IAE | Hematoxylin, Iron, Weigert'S | 1 | 1 | |
| IAF | Wright'S Stain | 1 | 33 | |
| ICC | Eosin B | 1 | 1 | |
| ICD | Darrow Red | 1 | 0 | |
| ICF | Crystal Violet For Histology | 1 | 5 | |
| ICG | Cresyl Violet Acetate | 1 | 0 | |
| ICH | Congo Red | 1 | 1 | |
| ICI | Hematoxylin, Chrome Alum | 1 | 0 | |
| ICJ | Carbol Night Blue | 1 | 1 | |
| ICL | Carbol Fuchsin | 1 | 4 | |
| ICM | Brilliant Yellow | 1 | 0 | |
| ICN | Biebrich Scarlet | 1 | 2 | |
| ICO | Best'S Carmine | 1 | 0 | |
| ICQ | Azure A | 1 | 0 | |
| ICR | Azocarmine B | 1 | 0 | |
| ICS | Azocarmine G | 1 | 0 | |
| ICT | Azan Counterstain | 1 | 0 | |
| ICX | Aniline | 1 | 1 | |
| ICY | Acid, Aniline, Fuchsin | 1 | 0 | |
| ICZ | Ammoniacal Silver Hydroxide Silver Nitrate | 1 | 0 | |
| IDA | Alcian Blue | 1 | 2 | |
| IDB | Aldehyde Fuchsin | 1 | 0 | |
| IDC | Acridine Orange | 1 | 4 | |
| IDD | Alizarin Red | 1 | 0 | |
| IDE | Acid, Hematein | 1 | 0 | |
| IDF | Acid, Fuchsin | 1 | 1 | |
| JCH | Esterase | 1 | 0 | |
| JCI | Acid Phosphatase, Cytochemical | 1 | 0 | |
| JTS | Stains, Microbiologic | 1 | 40 | |
| KFC | Methylene Blue, Tissue Stain | 1 | 7 | |
| KFD | Aniline Blue | 1 | 1 | |
| KFE | Neutral Red | 1 | 1 | |
| KJK | Auramine O | 1 | 2 | |
| KJL | Azure C | 1 | 0 | |
| KJM | Bismarck Brown Y | 1 | 0 | |
| KJN | Brilliant Cresyl Blue | 1 | 1 | |
| KJO | Brilliant Green | 1 | 0 | |
| KJP | Carmine | 1 | 0 | |
| KJQ | Chlorazol Black E | 1 | 0 | |
| KJR | Erythrosin B | 1 | 3 | |
| KJS | Ethyl Eosin | 1 | 0 | |
| KJT | Indigocarmine | 1 | 0 | |
| KJW | Janus Green B | 1 | 0 | |
| KJX | Jenner Stain | 1 | 1 | |
| KJY | Malachite Green | 1 | 1 | |
| KJZ | Martius Yellow | 1 | 0 | |
| KKA | Methyl Orange | 1 | 0 | |
| KKB | Methyl Violet 2b | 1 | 0 | |
| KKC | Methylene Violet | 1 | 0 | |
| KKD | Nigrosin | 1 | 0 | |
| KKE | Orange Ii | 1 | 0 | |
| KKF | Orcein | 1 | 0 | |
| KKG | Protargol S | 1 | 0 | |
| KKH | Tablet, Resazurin | 1 | 0 | |
| KKI | Rose Bengal | 1 | 0 | |
| KKJ | Sudan Iii | 1 | 1 | |
| KKK | Sudan Iv | 1 | 1 | |
| KKL | Thionin | 1 | 0 | |
| KKM | Methylene Blue Thiocyanate | 1 | 0 | |
| KKP | Solution, Silver Carbonate | 1 | 0 | |
| KKQ | Sodium Periodate | 1 | 0 | |
| KKR | Potassium Periodate | 1 | 0 | |
| KKS | Acid, Periodic | 1 | 0 | |
| KKT | Hematoxylin, Ehrlich'S | 1 | 0 | |
| KKW | Basic Fuchsin | 1 | 0 | |
| KQC | Stains, Hematology | 1 | 9 | |
| LED | Stains, Chemical Solution | 1 | 16 | |
| LEE | Stains, Dye Solution | 1 | 1 | |
| LEF | Stains, Dye Powder | 1 | 1 | |
| LGY | Trypan Blue | 1 | 1 |
