Home / 510(k) Clearances / DEN170029

510(k) DEN170029

PrimeStore MTM by Longhorn Vaccines and Diagnostics, LLC — Product Code QBD

DEN170029 is an FDA 510(k) premarket notification submitted by Longhorn Vaccines and Diagnostics, LLC for the device "PrimeStore MTM". The FDA issued a decision of De Novo Granted on March 19, 2018. The device falls under product code QBD (Microbial Nucleic Acid Storage And Stabilization Device), a Class II device regulated under 21 CFR 866.2950.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
March 19, 2018
Date Received
May 24, 2017
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microbial Nucleic Acid Storage And Stabilization Device
Device Class
Class II
Regulation Number
866.2950
Review Panel
MI
Submission Type

Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material.

Other clearances for product code QBD

  • K242820 — Puritan PurSafe Plus Collection and Transport System (May 27, 2025)
  • K240797 — PPH Saliva Collection Kit (October 11, 2024)
  • K222771 — Sample Preservative Fluid (June 26, 2024)
  • K233324 — Molecular Transport Media - MTM (June 17, 2024)
  • K221547 — InActiv Blue (June 11, 2024)
  • K212878 — Sample preservation solution (April 8, 2024)
  • K231013 — DNA/RNA Shield SafeCollect Saliva Collection kit (September 28, 2023)
  • K221664 — CLEARinse CTS Specimen Collection and Transport System (July 3, 2023)
  • K221802 — iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) (April 3, 2023)
  • K223497 — Spectrum Saliva Collection Device (February 17, 2023)

FDA data resources