Medical Genetics (MG) FDA Submissions
Browse FDA 510(k), De Novo, and PMA medical device clearances for the Medical Genetics (MG) review panel, including product codes, regulations, and cleared devices.
CFR Parts: Part 862, Part 864, Part 866
Subparts
- Part 862 Subpart D—Clinical Toxicology Test Systems — 1 product code
- Part 864 Subpart B—Biological Stains — 1 product code
- Part 866 Subpart D—Serological Reagents — 1 product code
- Part 866 Subpart G—Tumor Associated Antigen Immunological Test Systems — 4 product codes
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| QDJ | Direct-To-Consumer Access Pharmacogenetic Assessment System | 862.3364 | 2 | 3 |
| QDI | Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies | 864.1880 | 2 | 1 |
| QIC | Hiv-1 Genotyping Assay Using Ngs Technology | 866.3955 | 2 | 0 |
| QNC | Whole Exome Sequencing Constituent Device | 866.6000 | 2 | 1 |
| OYX | Bcr/Abl1 Monitoring Test | 866.6060 | 2 | 5 |
| PSU | Jak2 Gene Mutation Detection Test | 866.6070 | 2 | 2 |
| QAZ | Cancer Predisposition Risk Assessment System | 866.6090 | 2 | 4 |
