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OEPClass II

Influenza A Virus Subtype Differentiation Nucleic Acid Assay

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

OEP is the FDA product code for Influenza A Virus Subtype Differentiation Nucleic Acid Assay, a class II device type, regulated under 21 CFR 866.3980. FDA's definition for this code reads: "A qualitative in vitro diagnostic assay intended to detect and differentiate between influenza a virus subtypes in human respiratory specimens or viral culture. Detection and differentiation of specific subtype rna aids in the diagnosis of influenza caused by influenza a in conjunction with other clinical and...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OEP
Device name
Influenza A Virus Subtype Differentiation Nucleic Acid Assay
FDA definition
A qualitative in vitro diagnostic assay intended to detect and differentiate between influenza a virus subtypes in human respiratory specimens or viral culture. Detection and differentiation of specific subtype rna aids in the diagnosis of influenza caused by influenza a in conjunction with other clinical and laboratory testing in patients suspected of being infected with these viruses. Also, it aids in the presumptive laboratory identification of influenza a virus subtypes to provide epidemiological information on influenza.
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
1
Ingested recalls
0

Clearances, product code OEP

By decision year
1 clearance under product code OEP with a decision year between 2014 and 2014, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OEP by decision year
YearClearances
20141

Applicants with the most clearances

Product code OEP
Applicants holding the most 510(k) clearances under product code OEP
ApplicantClearances
Centers for Disease Control and Prevention1

Companies listing this code with FDA

Companies whose registered establishments list this code