QDZ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3181
- Medical specialty
- Microbiology
- FDA definition
- 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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| Record | Firm | Date |
|---|---|---|
| Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack (K202755) | Diasorin Molecular, LLC | 2022-11-05 |
| Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit (DEN180040) | Meridian Bioscience, Inc. | 2018-11-30 |
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