Name: Predicase
Price: 199 USD

K-number	K191578
Device name	ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	QFO
Device class	Class II
Decision date	Jul 17, 2019
Decision	Substantially Equivalent
Regulation	866.3935

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Source

View the full FDA submission: accessdata.fda.gov

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ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control

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