OMSClass II

Novel Influenza A Virus, A/H5 Ns1 Protein

21 CFR 866.3332 / Microbiology

OMS is the FDA product code for Novel Influenza A Virus, A/H5 Ns1 Protein, a class II device type, regulated under 21 CFR 866.3332. FDA's definition for this code reads: "Novel influenza A virus reagents are used to directly detect and differentiate novel influenza A virus specific nonstructural protein 1 (NS1) in human respiratory specimens or viral cultures. Detection and differentiation of specific NS1 protein aids in the diagnosis of influenza caused by novel influenza A viruses in...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2009-04-08, and no recalls.

Classification record

Product code: OMS
Device name: Novel Influenza A Virus, A/H5 Ns1 Protein
FDA definition: Novel influenza A virus reagents are used to directly detect and differentiate novel influenza A virus specific nonstructural protein 1 (NS1) in human respiratory specimens or viral cultures. Detection and differentiation of specific NS1 protein aids in the diagnosis of influenza caused by novel influenza A viruses in patients with clinical and epidemiological risk of infection with these viruses. They also aid in the presumptive identification of specific novel influenza A viruses and provide epidemiological information on influenza.
Regulation: 21 CFR 866.3332
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 OMS

By decision year

1 clearance under product code OMS with a decision year between 2009 and 2009, 2009 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code OMS by decision year
Year	Clearances
2009	1

Applicants with the most clearances

Product code OMS

Applicants holding the most 510(k) clearances under product code OMS
Applicant	Clearances
Arbor Vita Corportation	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OMS.

Recent clearances

Product code OMS

K083278Class IIAvc A/h5n1 Flu TestArbor Vita Corportation / cleared 2009-04-08

Recent recalls

Product code OMS

FDA records show no recalls under product code OMS.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)