K-number	DEN180069
Device name	ZIKV Detect 2.0 IgM Capture ELISA
Applicant	InBios International, Inc.
Product code	QFO
Device class	Class II
Decision date	May 23, 2019
Decision	Not Substantially Equivalent
Regulation	866.3935

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Source

View the full FDA submission: accessdata.fda.gov

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ZIKV Detect 2.0 IgM Capture ELISA

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