contrast agent
Defined in 1 dictionary — U.S. Code
United States Code
21 U.S.C. § 353 — in this section
The term "contrast agent" means an article that is intended for use in conjunction with a medical imaging device, and—
(i) is a diagnostic radiopharmaceutical, as defined in sections 315.2 and 601.31 of title 21, Code of Federal Regulations (or any successor regulations); or
(ii) is a diagnostic agent that improves the visualization of structure or function within the body by increasing the relative difference in signal intensity within the target tissue, structure, or fluid.
21 U.S.C. § 355 — under this section (7 versions over time)
the terms “applicable medical imaging device” and “contrast agent” have the meanings given such terms in section 360j(p) of this title.
21 U.S.C. § 360J — under this chapter (6 versions over time)
the term “contrast agent” means a drug that is approved under section 355 of this title or licensed under section 262 of title 42, is intended for use in conjunction with an applicable medical imaging device, and—
(i) is a diagnostic radiopharmaceutical, as defined in section 3 315.2 and 601.31 of title 21, Code of Federal Regulations (or any successor regulations); or
(ii) is a diagnostic agent that improves the visualization of structure or function within the body by increasing the relative difference in signal intensity within the target tissue, structure, or fluid.