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510(k) Data Aggregation
K Number
K221802Device Name
iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)
Manufacturer
Mawi DNA Technologies
Date Cleared
2023-04-03
(286 days)
Product Code
QBD, OBD
Regulation Number
866.2950Why did this record match?
Applicant Name (Manufacturer) :
Mawi DNA Technologies
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The iSWAB-Respiratory Tract Sample Collection Media-Extraction device is intended for the stabilization and inactivation of upper respiratory and saliva human specimens suspected of containing SARS-CoV-2. This device can be used for the collection, transport, and storage of specimens at ambient temperature. Specimens collected in the iSWAB-Respiratory Tract Sample Collection Media-Extraction Less collection device are suitable for use with legally marketed molecular diagnostic tests.
Device Description
The iSWAB™-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB™ -RC-EL) collection device consists of a collection tube that is pre-filled with 800 µL of the iSWAB™-RC-EL nontoxic, stabilizing buffer and fitted with a proprietary insert. The insert is designed to optimize the release of specimens collected with swabs into the stabilizing buffer, creating a minimal footprint and allowing for swab-free transport of specimens. The iSWAB™-RC-EL collection device eliminates the costly and timeconsuming RNA isolation step from diagnostic workflows.
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