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510(k) Data Aggregation
K Number
K141341Device Name
CL DETECT RAPID TEST
Manufacturer
INBIOS INTERNATIONAL INC.
Date Cleared
2014-11-14
(177 days)
Product Code
PIT
Regulation Number
866.3870Why did this record match?
Applicant Name (Manufacturer) :
INBIOS INTERNATIONAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CL Detect™ Rapid Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of Leishmania species antigen in ulcerative skin lesions. The test is intended for use with dental broach samples from less than four month old ulcerative skin lesions that are obtained from patients with suspected cutaneous leishmaniasis (CL). The test targets the peroxidoxin antigen of Leishmania species that may cause CL. The CL DetectTM Rapid To aid in the diagnosis of CL, and must be interpreted within the context of all relevant clinical and laboratory findings.
Device Description
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