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

Devices Detecting Influenza A, B, And C Virus Antigens

21 CFR 866.3328 / Microbiology
FDA source (opens on fda.gov)

PSZ is the FDA product code for Devices Detecting Influenza A, B, And C Virus Antigens, a class II device type, regulated under 21 CFR 866.3328. FDA's definition for this code reads: "An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection". As of , FDA records hold 72 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
PSZ
Device name
Devices Detecting Influenza A, B, And C Virus Antigens
FDA definition
An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.
Regulation
21 CFR 866.3328
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
73
Ingested recalls
5

Clearances, product code PSZ

By decision year
73 clearances under product code PSZ with a decision year between 1998 and 2026, 2013 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code PSZ by decision year
YearClearances
19982
19992
20001
20011
20022
20033
20043
20054
20063
20072
20081
20097
20105
20113
20122
20138
20141
20154
20163
20173
20185
20202
20232
20252
20262

Applicants with the most clearances

Product code PSZ
Applicants holding the most 510(k) clearances under product code PSZ
ApplicantClearances
Becton Dickinson & Co18
Ortho-Clinical Diagnostics, Inc.8
Meridian Bioscience Inc4
Princeton BioMeditech Corp.4
SA Scientific, Ltd4
Alere Scarborough, Inc.3
Binax, Inc.3
Binax, Inc.3
Genzyme Corporation3
Sekisui Diagnostics, LLC3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order