# K963425: Genzyme Diagnostics Contrast Mono

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Diagnostics
- Decided: Feb 25, 1997 after 179 days
- Product code: KTN (System, Test, Infectious Mononucleosis)
- Device class: 2
- Regulation: 21 CFR 866.5640
- 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) Quidel CONCISE® PLUS™ MONO: named in the summary without a submission number

## Indications for use
The qualitative detection of human IgM antibodies to heterophile antigen in serum, plasma or whole blood as an aid in the diagnosis of acute infectious mononucleosis for use in the physician’s office laboratory and the clinical laboratory.

Source page: https://510kreport.com/device/K963425
Methodology: https://510kreport.com/methodology