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Notes

§864.7290. Factor deficiency test.

21 C.F.R. § 864.7290

(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).
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]