Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
FDA 510(k) K202755 · Diasorin Molecular, LLC
510(k) numberK202755
Submission
- Device name
- Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
- Applicant
- Diasorin Molecular, LLC
Cypress, CA, US - Received
- September 21, 2020
- Decision date
- November 5, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QDZ – Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3181
- Specialty
- Microbiology
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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Questions and answers
When was Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack cleared by the FDA?
Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack (K202755) received a 510(k) decision of Substantially Equivalent on November 5, 2022, 775 days after the submission was received.
What is the product code of K202755?
The FDA product code is QDZ – Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection, a Class II (moderate risk) device regulated under 21 CFR 866.3181.