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510(k) Data Aggregation
K Number
K231027Device Name
KaiBiLi Extended ViralTrans
Date Cleared
2023-12-21
(254 days)
Product Code
Regulation Number
866.2390Why did this record match?
Applicant Name (Manufacturer) :
**Hangzhou Genesis Biodetection **& Biocontrol Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The KaiBiLi Extended ViralTrans is intended for the collection of clinical specimens containing viruses, chlamydiae, mycoplasmas and ureaplasmas from the collection site to the test site. The KaiBiLi Extended ViralTrans is a culture-based medium that has been validated with multiple sample types and can be used to process clinical specimens using standard laboratory operating procedures for culture of clinical specimens or with other assays that utilize stable recoverable infectious viral particles or bacteria.
Device Description
The KaiBiLi Extended ViralTrans is room temperature stable and can sustain the viability of virus, chlamydiae, mycoplasma and ureaplasma when transported at 2-8°C or 20-25°C. The product can maintain proper pH environment and inhibit the growth of indigenous microbiota.
KaiBiLi Extended ViralTrans consists of modified Hank's balanced salt solution supplemented with bovine serum albumin, cysteine, glutamic acid, sucrose and HEPES. The HEPES buffer protects against pH changes. Phenol red is used as a pH indicator. Sucrose aids in the preservation of organism viability. To minimize the contamination of commensal organisms, Vancomycin, Econazole Nitrate, and Polymyxin B are incorporated into the medium formula.
KaiBiLi Extended ViralTrans is supplied as one plastic flat-bottom vial along with a screw cap for safely containing and transporting biological specimens. The vial is filled with either 1 mL or 3 mL of transport medium and glass beads, or in a kit format together with collection swabs.
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