Universal Reagent Factor X Deficient Plasma
by Universal Reagents, Inc. 510(k)
Active
510(k) K964459
Overview
The Universal Reagent Factor X Deficient Plasma is a type of factor deficient coagulation plasma, specifically human plasma immunodepleted of Factor X. It is used in clinical laboratories for the in vitro diagnostic quantitative determination of Factor X levels via clotting assay, aiding in the diagnosis of congenital or acquired Factor X deficiency.
The device is supplied frozen or lyophilized and is used with various instruments and reagents. It has been cleared under FDA 510(k) number K964459, with a regulation number of 864.7290 and product code GGP. The device is classified as a class 2 device, with a medical specialty description of Hematology.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK964459 | Date18 Dec 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GGP
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7290
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Universal Reagents, Inc.
Questions
What is the Universal Reagent Factor X Deficient Plasma used for?
It is used in clinical laboratories for the in vitro diagnostic quantitative determination of Factor X levels via clotting assay, aiding in the diagnosis of congenital or acquired Factor X deficiency.
How is the device supplied?
The device is supplied frozen or lyophilized and is used with various instruments and reagents.
What is the regulatory status of the device?
The device has been cleared under FDA 510(k) number K964459, with a regulation number of 864.7290 and product code GGP, and is classified as a class 2 device.