510(k) · Cleared
ClearedLight Diagnostics Rabies Dfa Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Light Diagnostics · GOI Antiserum, Fluorescent, Rabies Virus
Cleared on Dec 22, 1998 after a 498-day review. The FDA summary names its predicate without a number.
- Decided
- Dec 22, 1998
- Review
- 498 days
- Class
- Class II
- Product code
- GOI
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GOI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | BECTON DICKINSON BBL® Anti-Rabies Globulin, Fluorescein Labeled Named without a submission number | |
| * | — | Centocor FITC Anti-Rabies Monoclonal Globulin Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All GOI devicesGOI Antiserum, Fluorescent, Rabies Virus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GOI
FDA has decided no GOI device since 2007.
Median 510(k) review, days · GOI
Too few GOI 510(k)s in any year since 2007 to give a median.
Recalls per year · GOI
No recall names GOI since 2007.
Adverse event reports per year · GOI
No MAUDE report names GOI since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972975 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972975: Light Diagnostics Rabies Dfa Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972975
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026