Part 866 Subpart D—Serological Reagents
FDA submissions for Part 866 Subpart D—Serological Reagents in the Pathology (PA) review panel, including product codes and regulations.
Section range: § 866.4001
CFR Part: 866
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| PZF | Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System | 866.4001 | 2 | 1 |
| QDS | Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System | 866.4001 | 2 | 3 |
