510(k) K103207

JBAIDS Q FEVER DETECTION KIT by Idaho Technology, Inc. — Product Code OVF

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 20, 2011
Date Received: November 1, 2010
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Assay, Direct, Nucleic Acid Amplification, Q Fever
Device Class: Class I
Regulation Number: 866.3500
Review Panel: MI
Submission Type

These reagents are nucleic acid primers and probes intended for the amplification and identification of Coxiella burnetii directly from clinical specimens. The identification aids in the diagnosis of Q Fever and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera or antigens.

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