Part 866 Subpart G—Tumor Associated Antigen Immunological Test Systems
FDA submissions for Part 866 Subpart G—Tumor Associated Antigen Immunological Test Systems in the Pathology (PA) review panel, including product codes and regulations.
Section range: §§ 866.6080–866.6100
CFR Part: 866
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| PZM | Next Generation Sequencing Based Tumor Profiling Test | 866.6080 | 2 | 7 |
| SBY | High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids | 866.6085 | 2 | 1 |
| QVU | High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System. | 866.6095 | 2 | 1 |
| QDC | Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies | 866.6100 | 2 | 2 |
