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510(k) Data Aggregation
K Number
K211707Device Name
BioTeke Sterile Disposable Virus Sampling Kit
Manufacturer
Date Cleared
2022-05-04
(335 days)
Regulation Number
866.2390Why did this record match?
Applicant Name (Manufacturer) :
BioTeke Corporation (WuXi) Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BioTeke Sterile Disposable Virus Sampling Kit is intended for the collection and transport of clinical specimens to the laboratory for standard diagnostic / identification techniques. The BioTeke Sterile Disposable Virus Sampling Kit consists of a sterile swab and culture-based media that can be used for respiratory viral diagnostic assays including, Influenza, Respiratory Syncytial Virus (RSV) A and B, Parainfluenza, Adenovirus, and Rhinovirus.
Device Description
The BioTeke Sterile Disposable Virus Sampling Swab Kit is a specimen collection and transport kit designed to collect a throat or nasal sample from the patient (utilizing the provided Specimen Collection Swab) and subsequently transferring the swab containing the patient's microbial sample into the provide 10mL polymer tube containing 3mL of VTM (Virus Transport Media)for purposes of transferring the swab and associated collected microorganisms into a transport container designed to preserve the sample during transport to the laboratory prior to laboratory analysis. The Specimen Collection Swab is designed with a break point (notched area on the shaft) to allow for the top of the VTM tube to close when the inoculated Specimen Collection Swab is placed into the BioTeke VTM tube.
The Bioteke Sterile Disposable Virus Sampling Swab Kit consists of the following: One (1) Specimen Collection Swab (sterile and individually packaged) One (1) Virus Transport Media (10mLpolymer tube containing 3mL of sterile VTM)
The Specimen Collection Swab measured 150mm with a breakpoint location (from the tip) at 80mm, a head length at 20mm and a head width of 3mm. The width of the Specimen Collection Swab measures 2.5mm. The 10mL polymer tubes are filled with 3mL of Virus Transport Media (VTM) and secured with a leak-proof polymer cap.
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