---
kind: "section"
citation: "21 C.F.R. § 864.7290"
title: "21"
number: "864.7290"
heading: "Factor deficiency test."
url: "https://uscodex.org/cfr/21/864.7290"
---

# §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).

## Notes

### 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]