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

2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification

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

OQW is the FDA product code for 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification, a class II device type, regulated under 21 CFR 866.3332. FDA's definition for this code reads: "2009 H1N1 influenza virus detection and identification reagents are used to directly detect and differentiate the 2009 H1N1 influenza virus in human respiratory specimens". As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OQW
Device name
2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
FDA definition
2009 H1N1 influenza virus detection and identification reagents are used to directly detect and differentiate the 2009 H1N1 influenza virus in human respiratory specimens
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
10
Ingested recalls
0

Clearances, product code OQW

By decision year
10 clearances under product code OQW with a decision year between 2010 and 2013, 2010 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code OQW by decision year
YearClearances
20103
20113
20121
20133

Applicants with the most clearances

Product code OQW
Applicants holding the most 510(k) clearances under product code OQW
ApplicantClearances
Centers for Disease Control and Prevention4
Cepheid2
Gen-Probe Prodesse, Inc.2
DiaSorin Molecular LLC1
U.S Army Medical Materiel Development Activity1

Companies listing this code with FDA

Companies whose registered establishments list this code