# K972316: Opus D-Dimer

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Sep 9, 1997 after 81 days
- Product code: GHH (Fibrin Split Products)
- Device class: 2
- Regulation: 21 CFR 864.7320
- 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) ASSERACHROM® D-Di: named in the summary without a submission number

## Indications for use
OPUS D-Dimer is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of cross-linked fibrin degradation products (XL-FDP) containing D-Dimer in human plasma, used in the diagnosis of thromboembolic events. OPUS D-Dimer is intended for use with the OPUS analyzers

Source page: https://510kreport.com/device/K972316
Methodology: https://510kreport.com/methodology