{"data":{"id":"us/21-cfr-864.7290","jurisdiction":"us","citation":"21 CFR 864.7290","heading":"Factor deficiency test.","body":"(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).\n(b) Classification. Class II (performance standards).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 864—HEMATOLOGY AND PATHOLOGY DEVICES","Subpart H—Hematology Kits and Packages"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"a2e10496da4e3be30d8029fa4ab49dc15bda70372c9719e9695a5c223301b74e","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.7280","next":"us/21-cfr-864.7293"},"notice":"GroundRules: Original legal text. Not legal advice."}