Part 864 Subpart E—Specimen Preparation Reagents
FDA submissions for Part 864 Subpart E—Specimen Preparation Reagents in the Pathology (PA) review panel, including product codes and regulations.
Section range: §§ 864.4010–864.4400
CFR Part: 864
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| HZI | Acid, Osmic | 864.4010 | 1 | 0 |
| IAL | Iodine (Tincture) | 864.4010 | 1 | 0 |
| IAM | Solution, Lugol'S | 864.4010 | 1 | 0 |
| IAT | Syrup, Gum, Apathy'S | 864.4010 | 1 | 0 |
| IAW | Collodion | 864.4010 | 1 | 0 |
| IAY | Colchicine | 864.4010 | 1 | 0 |
| IBB | Phytohemaglutinin M | 864.4010 | 1 | 0 |
| IER | Polyethylene Glycol (Carbowax) | 864.4010 | 1 | 1 |
| IEX | Gelatin | 864.4010 | 1 | 0 |
| IEZ | Celloidin | 864.4010 | 1 | 0 |
| IFF | Solution, Decalcifier, Electrolytic | 864.4010 | 1 | 0 |
| IFH | Solution, Zenker'S | 864.4010 | 1 | 2 |
| IFI | Sprays, Synthetic, Smear | 864.4010 | 1 | 1 |
| IFJ | Fixative, Richardson Glycol | 864.4010 | 1 | 0 |
| IFL | Polyethylene Glycol Preservative | 864.4010 | 1 | 0 |
| IFN | Solution, Orth'S | 864.4010 | 1 | 0 |
| IFO | Solution, Newcomer'S | 864.4010 | 1 | 0 |
| IFP | Formalin, Neutral Buffered | 864.4010 | 1 | 15 |
| IFQ | Formulations, Mercuric Chloride For Tissue | 864.4010 | 1 | 2 |
| IFS | Solution, Helly | 864.4010 | 1 | 0 |
| IFT | Glutaraldehyde | 864.4010 | 1 | 1 |
| IFY | Gelatin-Formalin | 864.4010 | 1 | 0 |
| IFZ | Gelatin For Specimen Adhesion | 864.4010 | 1 | 1 |
| IGB | Solution, Formalin-Sodium Acetate | 864.4010 | 1 | 1 |
| IGC | Formalin-Saline | 864.4010 | 1 | 2 |
| IGD | Solution, Formol Calcium | 864.4010 | 1 | 0 |
| IGE | Solution, Formalin Ammonium Bromide | 864.4010 | 1 | 2 |
| IGF | Solution, Formalin-Alcohol-Acetic Acid | 864.4010 | 1 | 1 |
| IGG | Formaldehyde (Formalin, Formol) | 864.4010 | 1 | 7 |
| IGK | Solution, Clarke'S | 864.4010 | 1 | 0 |
| IGM | Solution, Carnoy'S | 864.4010 | 1 | 3 |
| IGN | Fluid, Bouin'S | 864.4010 | 1 | 2 |
| IJZ | Oil, Clearing | 864.4010 | 1 | 1 |
| JCB | Detergent | 864.4010 | 1 | 0 |
| JCC | Ph Buffer | 864.4010 | 1 | 7 |
| JCE | Solution, Isotonic | 864.4010 | 1 | 7 |
| KDX | Solution, Decalcifier, Acid Containing | 864.4010 | 1 | 8 |
| KDY | Agent, Chelating For Decalcification | 864.4010 | 1 | 0 |
| KEE | Osmium Tetroxide | 864.4010 | 1 | 0 |
| KEF | Paraformaldehyde | 864.4010 | 1 | 0 |
| KEL | Adhesive, Albumin-Based | 864.4010 | 1 | 2 |
| KEM | Agent, Clearing | 864.4010 | 1 | 15 |
| KEO | Formulations, Paraffin, All | 864.4010 | 1 | 11 |
| KEP | Media, Mounting, Oil Soluble | 864.4010 | 1 | 3 |
| KEQ | Media, Mounting, Water Soluble | 864.4010 | 1 | 7 |
| LDW | Fixative, Acid Containing | 864.4010 | 1 | 4 |
| LDX | Fixative, Metallic Containing | 864.4010 | 1 | 1 |
| LDY | Fixative, Formalin-Containing | 864.4010 | 1 | 1 |
| LDZ | Fixative, Alcohol Containing | 864.4010 | 1 | 8 |
| LEA | Preservative, Cytological | 864.4010 | 1 | 4 |
| LEB | Mounting Media | 864.4010 | 1 | 5 |
| PPM | General Purpose Reagent | 864.4010 | 1 | 16 |
| MVU | Reagents, Specific, Analyte | 864.4020 | 1 | 0 |
| IAZ | Heparin | 864.4400 | 1 | 0 |
| IBA | Streptolysin O | 864.4400 | 1 | 0 |
| IBC | Diastase | 864.4400 | 1 | 0 |
| IBD | Hyaluronidase | 864.4400 | 1 | 0 |
| IBE | Neuramininase (Sialidase) | 864.4400 | 1 | 0 |
| IBF | Papain | 864.4400 | 1 | 0 |
| IBG | Trypsin | 864.4400 | 1 | 2 |
| LIJ | Peroxidase Anti-Peroxidase Immunohistochemical Stain | 864.4400 | 1 | 2 |
