§864.7290. Factor deficiency test.
21 C.F.R. § 864.7290
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).
Classification. Class II (performance standards).
Notes, amendments, and revision history
Amendments
[45 FR 60613, Sept. 12, 1980]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Amendments
[45 FR 60613, Sept. 12, 1980]