# K972975: Light Diagnostics Rabies Dfa Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Light Diagnostics
- Decided: Dec 22, 1998 after 498 days
- Product code: GOI (Antiserum, Fluorescent, Rabies Virus)
- Device class: 2
- Regulation: 21 CFR 866.3460
- 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) BECTON DICKINSON BBL® Anti-Rabies Globulin, Fluorescein Labeled: named in the summary without a submission number
- (no number) Centocor FITC Anti-Rabies Monoclonal Globulin: named in the summary without a submission number

## Indications for use
Light Diagnostics Rabies DFA Reagent is intended for the detection of rabies antigens in acetone-fixed tissues. Thus the assay could be used as an aid in the indirect diagnosis of human rabies virus infection. All specimens that are negative or indeterminate by DFA testing should be further tested by cell culture or animal inoculation methods.

Source page: https://510kreport.com/device/K972975
Methodology: https://510kreport.com/methodology