Title 21: Food and Drugs
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/ PART 864 - HEMATOLOGY AND PATHOLOGY DEVICES
/ Subpart H - Hematology Kits and Packages / § 864.7290 Factor deficiency test.
§ 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).