# K984596: Virastat Fitc-Labeled Anti-Influenza a and B Monoclonal Antibodies

- Pathway: 510(k) (Traditional)
- Applicant: Zymetx, Inc.
- Decided: Mar 4, 1999 after 66 days
- Product code: GNR (Antisera, Neutralization, 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
- (no number) Dako’s Imagen Influenza A and B Kit: named in the summary without a submission number

## Indications for use
The ViraSTAT® FITC-Labeled Anti-Influenza test panel is intended for the qualitative detection and confirmation of influenza A and B virus isolates from infected cell cultures through the use of the ViraSTAT® FITC-Labeled Anti-Influenza Pool and the identification and confirmation of influenza A and B by typing with separate ViraSTAT® FITC-Labeled Anti-Influenza type A or B, monoclonal antibodies, respectively. Performance characteristics have not been established for direct specimen staining.

Source page: https://510kreport.com/device/K984596
Methodology: https://510kreport.com/methodology