# K962037: Imagen Respiratory Screen

- Pathway: 510(k) (Traditional)
- Applicant: Dako Diagnostics, Ltd.
- Decided: Dec 26, 1996 after 216 days
- Product code: GNW (Antisera, Cf, Influenza Virus A, B, C)
- Device class: 1
- Regulation: 21 CFR 866.3330
- 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) Bartels Viral Respiratory Screening and Identification Kit: named in the summary without a submission number

## Indications for use
The IMAGEN™ Respiratory Screen is a qualitative indirect immunofluorescence test for the detection of Respiratory Syncytial Virus, Influenza A virus, Parainfluenza virus type 3 and Adenovirus directly in respiratory specimens and Respiratory Syncytial Virus, Influenza A and >B virus, Parainfluenza virus types 1, 2 and 3 and Adenovirus in cell culture monolayers.

Source page: https://510kreport.com/device/K962037
Methodology: https://510kreport.com/methodology