Part 866 Subpart E—Immunology Laboratory Equipment and Reagents
FDA submissions for Part 866 Subpart E—Immunology Laboratory Equipment and Reagents in the Immunology (IM) review panel, including product codes and regulations.
Section range: §§ 866.4070–866.4900
CFR Part: 866
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| NTW | System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test | 866.4070 | 2 | 2 |
| OZF | Tissue Rna Preservative For Collection, Storage, And Transportation | 866.4070 | 2 | 1 |
| DHL | Protein, Complement, Antigen, Antiserum, Control | 866.4100 | 1 | 4 |
| KTQ | Reagent, Complement | 866.4100 | 1 | 6 |
| JZS | Electrophoresis Instrumentation | 866.4500 | 1 | 6 |
| JZT | Fluorometer | 866.4520 | 1 | 14 |
| JZW | Nephelometer | 866.4540 | 1 | 11 |
| JZP | Plates, Ouchterlony Agar | 866.4600 | 1 | 1 |
| NTH | System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays | 866.4700 | 2 | 8 |
| OYU | Dna-Probe Kit, Human Chromosome | 866.4700 | 2 | 3 |
| PIV | Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use | 866.4750 | 2 | 2 |
| JZQ | Plates And Equipment, Radial Immunodiffusion | 866.4800 | 1 | 7 |
| JZX | Equipment, Rocket Immunoelectrophoresis | 866.4830 | 1 | 1 |
| JZR | Support Gels | 866.4900 | 1 | 2 |
