Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
K-Number: K202755 · 2022-11-05
Device Summary
Frequently Asked Questions
What is the Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack?
Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack is a medical device that received FDA 510(k) clearance on 2022-11-05. The listed applicant is Diasorin Molecular, LLC. The 510(k) number is K202755.
When did Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack receive FDA 510(k) clearance?
Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack received FDA 510(k) clearance on 2022-11-05, under 510(k) number K202755.
Who is the listed applicant for Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack?
The FDA 510(k) record lists Diasorin Molecular, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack?
The FDA product code for Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack is QDZ.
Other records listing Diasorin Molecular, LLC as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.