Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
The Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection is an in vitro diagnostic test for the direct detection of Cytomegalovirus (CMV) DNA in saliva from newborn babies, intended to aid in the diagnosis of congenital CMV infection. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 866.3181 in the Microbiology specialty. The product code is QDZ. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QDZ
- Device Class
- FDA class 2
- Regulation Number
- 866.3181
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
The device is a qualitative, in vitro diagnostic test for the direct detection of Cytomegalovirus (CMV) DNA in saliva from newborn babies.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K202755 | Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack | Nov 05, 2022 | Substantially Equivalent | Diasorin Molecular, LLC |
| DEN180040 | Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit | Nov 30, 2018 | Unknown | Meridian Bioscience, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.