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510(k) K202755

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack by Diasorin Molecular, LLC — Product Code QDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2022
Date Received
September 21, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
Device Class
Class II
Regulation Number
866.3181
Review Panel
MI
Submission Type

The device is a qualitative, in vitro diagnostic test for the direct detection of Cytomegalovirus (CMV) DNA in saliva from newborn babies.

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  • K183223 — Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (December 19, 2018)
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Other clearances for product code QDZ

  • DEN180040 — Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit (November 30, 2018)