# K972116: Von Willebrand Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Jul 25, 1997 after 50 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Helena Laboratories Ristocetin Cofactor Assay: named in the summary without a submission number

## Indications for use
Von Willebrand Reagent is used for the determination of ristocetin cofactor activity in human plasma. The determination.of ristocetin cofactor activity is important in: o The diagnosis of Von Willebrand’s disease. e The diagnosis of diseases characterized by changes in the ristocetin cofactor. e Pre-operatve screening of haemorrhagic diatheses.

Source page: https://510kreport.com/device/K972116
Methodology: https://510kreport.com/methodology