Search Results
Found 2 results
510(k) Data Aggregation
K Number
K233324Device Name
Molecular Transport Media - MTM
Manufacturer
ALB Luz
Date Cleared
2024-06-17
(262 days)
Product Code
QBD
Regulation Number
866.2950Why did this record match?
Applicant Name (Manufacturer) :
ALB Luz
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Molecular Transport Media - MTM is intended for the stabilization, and direct lysis of infectious unprocessed nasopharyngeal samples suspected of containing SARS COV-2 virus RNA. These devices can be used for the collection transport and storage of specimens at 15-35 °C. Specimens collected and stored in a Molecular Transport Media are suitable for use with legally marketed molecular diagnostic devices.
Device Description
The MTM consists of a pre-filled plastic tube containing either 2 or 3 mL of proprietary liquid medium intended for viral nucleic acid stabilization and transportation and inactivation of nasopharyngeal swab specimens suspected of containing SARS-CoV-2. MTM is intended for use with standard diagnostic/identification techniques that have been adequately validated and found to be compatible with the MTM. The formulation of the MTM includes guanidine-free inactivation buffer, salts, a buffer to maintain a neutral pH, and distilled water.
Ask a Question
K Number
K232454Device Name
Viral Transport Media (VTM)
Manufacturer
ALB Luz
Date Cleared
2024-05-03
(263 days)
Product Code
JSM
Regulation Number
866.2390Why did this record match?
Applicant Name (Manufacturer) :
ALB Luz
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ALB Luz Viral Transport Media is intended for the collection and transport of upper respiratory clinical specimens containing Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus from the collection site to the testing laboratory. The Viral Transport Media is a culture-based media that is intended to be used with standard diagnostic/identification techniques that utilize stable recoverable infectious viral particles.
Device Description
The Viral Transport Medium (VTM) is a non-propagating transport device composed of a culturebased media without swabs. The VTM is designed to preserves upper respiratory samples collected from a patient by placing the sample into the polymer tube containing 3 mL of media. The sample and media are then secured with a leak-proof screwcap for transportation.
The VTM maintains cellular integrity and preservation of viruses when properly stored. Prior to use, vials should be stored at 2℃ to 35℃. After specimen collection, the transport tube containing the specimen can be stored for up to 48 hours at either 2-8°C or 20-25°C, for transportation to the laboratory and storage. The medium has been evaluated for storage of the following respiratory viruses, Influenza A, Respiratory Syncytial Virus (RSV), and Rhinovirus, for viral recovery.
Ask a Question
Page 1 of 1