Official websites use .gov
A
.gov website belongs to an official
government organization in the United States.
Secure .gov websites use HTTPS
A lock (
) or https:// means you've safely
connected to the .gov website. Share sensitive
information only on official, secure websites.
Major Elements in the Evaluation of a New In Vitro Diagnostic Device for a Respiratory Pathogen
| 1 | Intended Use |
| 2 | Reference Methods and Clinical Studies |
| 3 | Assay Interpretation |
| 4 | Assay Performance Characteristics |
| 5 | Evaluating Multiplex Assays |
| 6 | CLIA Waivers |
