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PrimeStore MTM

Model PSMTM-1203-100 · Longhorn Vaccines And Diagnostics, LLC · DI B90312032

QBD — Microbial Nucleic Acid Storage And Stabilization Device · Class II · 21 CFR 866.2950

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

No dated reports to chart.

Regulatory clearances

  • DEN170029 DENG 2018-03-19 (k number procode)
  • DEN170029 DENG 2018-03-19 (k number procode)

Manufacturer compliance record — Longhorn Vaccines And Diagnostics, LLC

  • Warning Letter 2026-02-27 Longhorn Vaccines And Diagnostics LLC
  • Warning Letter 2026-02-27 Longhorn Vaccines And Diagnostics LLC
  • OAI 2025-10-30 Longhorn Vaccines And Diagnostics LLC · 2 citations
  • OAI 2025-10-30 Longhorn Vaccines And Diagnostics LLC · 2 citations