# K950838: Virazyme Culture Confirmation Screen for Influenza and Parainfluenza Viruses

- Pathway: 510(k) (Traditional)
- Applicant: Zymetx, Inc.
- Decided: Jun 17, 1996 after 479 days
- Product code: GNT (Antigens, Ha (Including Ha Control), 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 no predicate by number.

## Indications for use
The ViraZyme® Culture Confirmation Screen for Influenza and Parainfluenza is intended for use as a screening test for respiratory viral cultures infected with influenza type A and B and parainfluenza types 1, 2, 3, and 4. This test will screen culture fluids for the presence of these viruses, but it is not indented for the definitive typing of these viruses.

Source page: https://510kreport.com/device/K950838
Methodology: https://510kreport.com/methodology