510(k) Report

FDA applicant

Longhorn Vaccines and Diagnostics, LLC

Bethesda, MD1 decision2018–20180 recalls

FDA records 1 decision for Longhorn Vaccines and Diagnostics, LLC (Bethesda, MD) in 2018: 1 De Novo grant. All are in product code QBD (Microbial Nucleic Acid Storage And…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Longhorn Vaccines and Diagnostics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Longhorn Vaccines and Diagnostics, LLC by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Longhorn Vaccines and Diagnostics, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • QBDMicrobial Nucleic Acid Storage And Stabilization Device1decision

Who builds on its devices?

Later devices cite its devices 6 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN170029PrimeStore MTMLonghorn Vaccines and Diagnostics, LLC · 20186cite it

What has FDA decided for it lately?

  • DEN170029PrimeStore MTMLonghorn Vaccines and Diagnostics, LLC · 2018

The one decision as Longhorn Vaccines and Diagnostics, LLC →