510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K202755Substantially Equivalent

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack

DiaSorin Molecular LLC, Cypress CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202755 is the FDA 510(k) clearance record for Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack, a class II device, cleared for Diasorin Molecular, LLC on under FDA product code QDZ (Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection). FDA's definition for product code QDZ reads: "The device is a qualitative, in vitro diagnostic test for the direct detection of Cytomegalovirus (CMV) DNA in saliva from newborn babies". FDA records list 32 510(k) clearances for Diasorin Molecular, LLC, from to . As of , FDA records show no recalls naming K202755.

Clearance record

Decision date
Received
(775 days to decision)
Product code
QDZ Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
Regulation
21 CFR 866.3181
Device class
Class II
Review panel
Microbiology
Applicant
Diasorin Molecular, LLC 11331 Valley View St., Cypress CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QDZ

Trailing 12 months

FDA records hold no clearances under product code QDZ in the trailing twelve months.

FDA records show no clearances under product code QDZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QDZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260