12 results
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68ms
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Sources: EU EUDAMED, US FDA
Longhorn Vaccines and Diagnostics LLC
FDA registration
Longhorn Vaccines and Diagnostics LLC·1 product·🇺🇸 United States
PrimeStore MTM
FDA UDI
Longhorn Vaccines And Diagnostics, LLC·B90305153·PrimeStore MTM 5ml tube 1.5 ml fill Box of 1000
PrimeStore MTM
FDA UDI
Longhorn Vaccines And Diagnostics, LLC·B90305154·PrimeStore MTM 5ml tube 1.5ml fill Box of 500
PrimeStore MTM
FDA UDI
Longhorn Vaccines And Diagnostics, LLC·B9030315·PrimeStore MTM 3ml tube with 1.5 ml fill in bag...
PrimeStore MTM
FDA UDI
Longhorn Vaccines And Diagnostics, LLC·B90312032·PrimeStore MTM 12mL tube 3ml fill
PrimeStore MTM
FDA UDI
Longhorn Vaccines And Diagnostics, LLC·B90305151·PrimeStore MTM 5 ml tubes with 1.5 ml fill in 5...
PrimeStore MTM
FDA UDI
Longhorn Vaccines And Diagnostics, LLC·B9030201·PrimeStore MTM 2 ml tube with 1 ml fill in bag ...
PrimeStore MTM
FDA UDI
Longhorn Vaccines And Diagnostics, LLC·B90312022·PrimeStore MTM 12ml tube 2mL fill
PrimeStore MTM
FDA UDI
Longhorn Vaccines And Diagnostics, LLC·B90312033·PrimeStore MTM 12ml tube 3ml fill carton of 1000
PrimeStore MTM
FDA UDI
Longhorn Vaccines And Diagnostics, LLC·B90312023·PrimeStore MTM 12ml tube 2ml fill Carton of 1000
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 nasal washes, nasopharyngeal, oral/throat swabs* suspected of containing Influenza A virus RNA. PS-MTM is also intended for the stabilization, transportation, and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis (MTB) DNA from human samples.
FDA Enforcement
Class II
·Ongoing·LONGHORN VACCINES AND DIAGNOSTIC·September 23, 2020
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 nasal washes, nasopharyngeal, oral/throat swabs* suspected of containing Influenza A virus RNA. PS-MTM is also intended for the stabilization, transportation, and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis (MTB) DNA from human samples.
FDA Recall
Open, Classified
·LONGHORN VACCINES AND DIAGNOSTIC 2 Bethesda Metro Cente·Product code QBD·June 3, 2020