21 C.F.R. § 864.7290

Current through October 31, 2024
Section 864.7290 - Factor deficiency test
(a)Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).
(b)Classification. Class II (performance standards).

21 C.F.R. §864.7290

45 FR 60613, Sept. 12, 1980