# K022713: Dfa Respiratory Virus Screening & ID Kit

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Hybrids, Inc.
- Decided: Dec 18, 2002 after 126 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.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices 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) Diagnostic Hybrids, Inc. IFA Respiratory Viruses Screening and Identification Kit: named in the summary without a submission number

## Most influential descendants
- K061101: D3 Ultra Dfa Respiratory Virus Screening & ID Kit (2006), 7 descendants of its own
- K081928: D3 Duet Dfa RSV/Respiratory Virus Screening Kit (2008), 4 descendants of its own
- K093415: D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus Identification Kit (2009), 0 descendants of its own
- K093233: D3 Fastpoint L-Dfa RSV/MVP Identification Kit (2009), 0 descendants of its own
- K092882: D3 Fastpoint L-Dfa Influenza a/Influenza B Virus Identification Kit (2009), 0 descendants of its own

## Indications for use
The Diagnostic Hybrids, Inc. DFA (Direct Fluorescent Antibody) Respiratory Virus Screening & ID Kit is intended for the qualitative detection and identification of the common respiratory viruses, Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), Adenovirus, Parainfluenza 1, Parainfluenza 2 and Parainfluenza 3 in direct specimens and cell cultures. It is recommended that specimens found to be negative after examination of the direct specimen result be confirmed by cell culture.

Source page: https://510kreport.com/device/K022713
Methodology: https://510kreport.com/methodology