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 Obstetrics/Gynecology (OB) review panel, including product codes and regulations.
Section range: § 866.6050
CFR Part: 866
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| ONX | Ovarian Adnexal Mass Assessment Score Test System | 866.6050 | 2 | 6 |