Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit

K Number: DEN180040 · Decision Nov 30, 2018

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Review Days

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Device Name: Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
K Number: DEN180040
Device Class: FDA class 2
Clearance Type: Direct
Regulation Number: 866.3181
Medical Specialty: Microbiology
Decision: Unknown
Applicant: Meridian Bioscience, Inc.
Date Received: July 30, 2018
Decision Date: November 30, 2018
Product Code: QDZ
Advisory Committee: Microbiology
Review Advisory Committee: MI
Third Party: N

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code	Device Name	Device Class	Medical Specialty
QDZ	Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection	FDA class 2	Microbiology

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