DeviceClearance

Product code OMS— Microbiology

AVC A/H5N1 FLU TEST

Classification name
Novel Influenza A Virus, A/H5 Ns1 Protein
Device class
Class 2
Regulation
21 CFR 866.3332
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OMS under 21 CFR 866.3332, via openFDA

Market context for product code OMS

FDA has cleared 1 device under product code OMS, all in 2009, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OMS

Recent clearances under product code OMS

Data sourced from openFDA. This site is unofficial and independent of the FDA.