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

Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna

21 CFR 866.3332 / Microbiology
FDA source (opens on fda.gov)

NXD is the FDA product code for Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna, 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 in nucleic acid amplification tests to directly detect and differentiate novel influenza a virus specific rna gene segments in human respiratory specimens or viral cultures. Detection and differentiation of specific rna gene segments aids in the diagnosis of influenza caused...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NXD
Device name
Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna
FDA definition
Novel influenza a virus reagents are used in nucleic acid amplification tests to directly detect and differentiate novel influenza a virus specific rna gene segments in human respiratory specimens or viral cultures. Detection and differentiation of specific rna gene segments 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. These reagents are primers and probes, along with a specific novel influenza virus control.
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
3
Ingested recalls
0

Clearances, product code NXD

By decision year
3 clearances under product code NXD with a decision year between 2006 and 2010, 2006 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NXD by decision year
YearClearances
20061
20081
20101

Applicants with the most clearances

Product code NXD
Applicants holding the most 510(k) clearances under product code NXD
ApplicantClearances
Centers for Disease Control and Prevention2
U.S. Army Medical Material Development Command1

Companies listing this code with FDA

Companies whose registered establishments list this code