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510(k) Data Aggregation
K Number
K202531Device Name
Azer Scientific Universal Transport Medium
Manufacturer
Azer Scientific, Inc.
Date Cleared
2024-04-11
(1318 days)
Product Code
JSM
Regulation Number
866.2390Why did this record match?
Applicant Name (Manufacturer) :
Azer Scientific, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Azer Scientific Universal Transport Medium is for the collection and transport of upper respiratory clinical specimens. containing respiratory viruses from the to the testing laboratory. The Azer Scientific Universal Transport Medium is a culture-based media that can be processed usincal laboratory operating procedures for the isolation and detection of upper respiratory viruses including Influenza A, Respiratory Syncytial Virus (RSV) and Adenovirus.
Device Description
The Azer Scientific Universal Transport Medium includes a plastic screw-cap tube with conical bottom containing 3 mL of transport medium and three, 3 mm size glass beads. Azer Scientific Universal Transport Medium tubes can be supplied alone or in a kit format with one of three different collection swab options in a sterile peel pouch.
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