510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243274Substantially Equivalent

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)

Centers for Disease Control and Prevention, Atlanta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243274 is the FDA 510(k) clearance record for CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4), a class II device, cleared for Centers for Disease Control and Prevention on under FDA product code OZE (Influenza A And Influenza B Multiplex Nucleic Acid Assay). FDA's definition for product code OZE reads: "An Influenza A and Influenza B multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of influenza A and influenza B nucleic acids isolated and purified from human...". FDA records list 30 510(k) clearances for Centers for Disease Control and Prevention, from to . As of , FDA records show no recalls naming K243274.

Clearance record

Decision date
Received
(268 days to decision)
Product code
OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay
Regulation
21 CFR 866.3980
Device class
Class II
Review panel
Microbiology
Applicant
Centers for Disease Control and Prevention 1600 Clifton Rd., Atlanta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OZE

Trailing 12 months

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

FDA records show no clearances under product code OZE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OZE, 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