Data / Medical devices / United States / Longhorn Vaccines and Diagnostics LLC
Longhorn Vaccines and Diagnostics LLC: FDA-registered device maker in Bethesda, MD, United States, 1 510(k) clearance
Longhorn Vaccines and Diagnostics LLC is registered with the FDA (registration 3011818318) in Bethesda, MD, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 19, 2018. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011818318
- Address
- 7272 Wisconsin Avenue Suite 900, Bethesda, MD, United States, 20814
- Owner or operator
- Longhorn Vaccines and Diagnostics LLC (10077988)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 7, 2020
- Registered through
- 2026
- Brand names listed
- PrimeStore MTM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Microbial Nucleic Acid Storage And Stabilization Device | QBD | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 19, 2018 | DEN170029 | PrimeStore MTM | QBD | Unknown | Longhorn Vaccines and Diagnostics, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 3, 2020 | 86189 | Class II | Ongoing | PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, transportation, and inactivation of infectious unprocessed na | The tubes may have been delivered to some users without labels. Users may not be able to identify the tubes without these labels. If samples stored or transported in tubes are tested on certain systems or come into contact with bleach they can produce cyanide gas. The solution in these tubes contains guanidine thiocynate and may put laboratory personnel at r | accessdata.fda.gov |
Compare with other makers
Updated March 19, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.