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

Parainfluenza Multiplex Nucleic Acid Assay

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

OOU is the FDA product code for Parainfluenza Multiplex Nucleic Acid Assay, a class II device type, regulated under 21 CFR 866.3980. FDA's definition for this code reads: "A parainfluenza multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus nucleic acids isolated and purified from human respiratory specimens...". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OOU
Device name
Parainfluenza Multiplex Nucleic Acid Assay
FDA definition
A parainfluenza multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus 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 human parainfluenza nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract parainfluenza 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
5
Ingested recalls
0

Clearances, product code OOU

By decision year
5 clearances under product code OOU with a decision year between 2009 and 2017, 2009 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OOU by decision year
YearClearances
20091
20131
20141
20151
20171

Applicants with the most clearances

Product code OOU
Applicants holding the most 510(k) clearances under product code OOU
ApplicantClearances
Hologic, Inc.2
Gen-Probe Prodesse, Inc.1
Prodesse, Inc.1
Ortho-Clinical Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code