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510(k) Data Aggregation
K Number
K222771Device Name
Sample Preservative Fluid
Manufacturer
Hangzhou Bioer Technology Co., LTD
Date Cleared
2024-06-26
(651 days)
Product Code
QBD
Regulation Number
866.2950Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou Bioer Technology Co., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sample Preservative Fluid is intended for the stabilization, and inactivation of infectious, unprocessed, upper respiratory specimens suspected of containing Influenza A virus. Specimens transported in the Sample Preservative Fluid are stable refrigerated (2-8°C) and at room temperature (20-25°C). The Sample Preservative Fluid is suitable for use with compatible legally marketed molecular diagnostic devices.
Device Description
Sample Preservative Fluid is a medium for stabilization of Influenza A RNA during sample transport/storage. The fluid is composed of quanidine thiocyanate, Triton X-100, and nuclease-free water. Sample Preservative Fluid is provided in a labeled screw-cap tube.
Sample Preservative Fluid configuration:
- BSC82X1-A1: a screw-cap tube filled with 2 mL of Sample Preservative Fluid liquid ● and a prepackaged nasopharyngeal swab for sample collection
- Nasopharyngeal swab: regular size, sterile disposable sample swab (80mm . breakpoint)
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