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

ImmunoCard Stat! FLU A&B

Name: ImmunoCard Stat! FLU A&B
Brand: ImmunoCard Stat! FLU A&B

ImmunoCard STAT! Flu A&B is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly form nasal swab, nasopharyngeal swab, and…

Registry build 21.09.26

ImmunoCard STAT! Flu A&B is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly form nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Moderate Complexity when used with Nasal Wash/Aspirate Samples. CLIA Waived when used with Nasal and Nasopharyngeal Swabs.

2manufacturers in China registered for this device type

1catalogue number

4510(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 ImmunoCard Stat! FLU A&B
Listed by	Meridian Bioscience, 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
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K083746
Record published	2018-03-12
Record revised	2022-06-10 (version 3)

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
Storage	Storage environment temperature 2 to 30 °C

Catalogue Numbers

Catalogue numbers for ImmunoCard Stat! FLU A&B
Catalogue number	Size	Status
782030		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
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
Acucy Calibration Device	Sekisui Diagnostics, LLC	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
K133714	2014-01-03
K092553	2009-09-11
K071657	2007-11-15
K041626	2005-03-16

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.