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

Influenza A And Influenza B Multiplex Nucleic Acid Assay

21 CFR 866.3980 / Microbiology
FDA source (opens on fda.gov)

OZE is the FDA product code for Influenza A And Influenza B Multiplex Nucleic Acid Assay, a class II device type, regulated under 21 CFR 866.3980. FDA's definition for this code 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 respiratory specimens obtained from individuals exhibiting signs and symptoms...". As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
OZE
Device name
Influenza A And Influenza B Multiplex Nucleic Acid Assay
FDA definition
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 respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of influenza A and B nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract influenza viral infections if used in conjunction with other clinical and laboratory findings.
Regulation
21 CFR 866.3980
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
20
Ingested recalls
5

Clearances, product code OZE

By decision year
20 clearances under product code OZE with a decision year between 2012 and 2025, 2014 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code OZE by decision year
YearClearances
20121
20132
20143
20151
20161
20171
20182
20193
20201
20221
20231
20241
20252

Applicants with the most clearances

Product code OZE
Applicants holding the most 510(k) clearances under product code OZE
ApplicantClearances
Centers for Disease Control and Prevention9
Centers for Disease Control and Prevention (CDC)3
Ortho-Clinical Diagnostics, Inc.3
Abbott Diagnostics Scarborough, Inc.1
Alere Scarborough, Inc.1
Center for Disease Control and Prevention (Cdc)1
Indevr, Inc.1
Mesa Biotech, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order