510(k) K181473

DENV Detect NS1 ELISA by InBios International, Inc. — Product Code QCU

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 27, 2018
Date Received: June 4, 2018
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Dengue Virus Antigen Assay
Device Class: Class II
Regulation Number: 866.3945
Review Panel: MI
Submission Type

Qualitative detection of Dengue virus antigen in human serum or plasma collected from human patients with signs and symptoms consistent with Dengue virus infection

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