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510(k) Data Aggregation
K Number
DEN170029Device Name
PrimeStore MTM
Manufacturer
Longhorn Vaccines and Diagnostics LLC
Date Cleared
2018-03-19
(299 days)
Product Code
QBD
Regulation Number
866.2950Why did this record match?
Applicant Name (Manufacturer) :
Longhorn Vaccines and Diagnostics LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PrimeStore MTM is intended for the stabilization, transportation and inactivation of infectious unprocessed nasal washes suspected of containing Influenza A virus RNA. PrimeStore MTM is also intended for the stabilization, transportation and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis DNA from human samples.
Device Description
The PrimeStore MTM device consists of a storage tube with an O-ring and lip seal containing 1.5 mL of the stabilization solution. These components are intended to inactivate Influenza A and Mycoplasma tuberculosis, lyse cells, disrupt/lyse lipid membranes, denatures proteins, inactivates enzymes, and stabilize Influenza A RNA and M. tuberculosis DNA. The transport device is designed for storage of specimens between 36-77 °F (2-25 °C).
The media contains the following reagents:
- o Guanidine thiocyanate
- o TCEP
- Sodium Citrate ●
- N-Lauroylsarcosine sodium (NLS) ●
- Antifoam A, TRIS ●
- EDTA ●
- Ethanol (molecular grade)
- HCl ●
- Nuclease-free water ●
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