What is FDA product code PSZ?

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.

Immunology & Microbiology › Serological ReagentsDevices Detecting Influenza A, B, And C Virus Antigens

BinaxNOW Influenza a & B Card 2 Control Swab Kit

Name: BinaxNOW Influenza A & B Card 2 Control Swab Kit
Brand: BinaxNOW Influenza A & B Card 2 Control Swab Kit

Control Swabs ntended for use only with BinaxNOW™ Influenza A & B 2 Card product.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

Concentrated in elsewhere (1), Hebei (1).

Chinese manufacturers registered for FDA product code PSZ
Manufacturer	City	Province	Registered as	Device types
BD Rapid Diagnostics (Suzhou) Co., Ltd.	China (Jiangsu) Pilot Free Trade Zone Suzhou Area		Manufacturer	6
Innovita (Tangshan) Biological Technology Co., Ltd.	Qian’An	Hebei	Manufacturer	5

Record

Regulatory record for BinaxNOW Influenza A & B Card 2 Control Swab Kit
Listed by	Alere Scarborough, Inc., United States
FDA product code	PSZ
Device type	Devices Detecting Influenza A, B, And C Virus Antigens
Device class	Class 2
Regulation	21 CFR 866.3328
Record published	2019-07-15
Record revised	2023-09-12 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for BinaxNOW Influenza A & B Card 2 Control Swab Kit
Catalogue number	Size	Status
575-080		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waived kit	Becton, Dickinson AND Company	2
Fluoro-CheckTM Influenza A+B	Nano-Ditech Corporation	1
Acucy Flu Test Kit	Sekisui Diagnostics, LLC	1
Acucy System	Sekisui Diagnostics, LLC	1
ImmunoCard Stat! FLU A&B	Meridian Bioscience, Inc.	1
Alere BinaxNOW Influenza A & B Card 2	Alere Scarborough, Inc.	1
Osom Ultra Plus FLU A&B Test	Sekisui Diagnostics, LLC	1
BD Veritor™ System CLIA-Waived Combo Pack	Becton, Dickinson AND Company	1
ID NOW Influenza A & B 2	Alere Scarborough, Inc.	1
Acucy System Universal Drawer	Sekisui Diagnostics, LLC	1
Osom Ultra Plus FLU A&B Control Kit	Sekisui Diagnostics, LLC	1
BinaxNOW Influenza A & B Card 2	Alere Scarborough, Inc.	1

Showing 12 of 26. All products under Devices Detecting Influenza A, B, And C Virus Antigens

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K181853	2018-08-08
K173502	2017-12-13
K162642	2017-04-10

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.