21 CFR 864.7290
§ 864.7290 Factor deficiency test.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 864.7290, § 864.7290 Factor deficiency test, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89367
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.