What is FDA product code OZE?

An Influenza A and Influenza B multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of influenza A and influenza B nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of influenza A and B nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract influenza viral infections if used in conjunction with other clinical and laboratory findings.

Immunology & Microbiology › Serological ReagentsInfluenza A And Influenza B Multiplex Nucleic Acid Assay

Aries® Flu A/B & RSV Assay

Name: Aries® Flu A/B & RSV Assay
Brand: Aries® Flu A/B & RSV Assay

The ARIES® Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of influenza A virus, influenza B…

Registry build 21.09.26

The ARIES® Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swabs (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings.

1manufacturer

1catalogue number

1recall

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OZE
Manufacturer	City	Province	Registered as	Device types
Hochuen Medical Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	20

Record

Regulatory record for Aries® Flu A/B & RSV Assay
Listed by	Luminex Corporation, United States
FDA product code	OZE
Device type	Influenza A And Influenza B Multiplex Nucleic Acid Assay
Device class	Class 2
Regulation	21 CFR 866.3980
Establishment	Contract manufacturer, Remanufacturer, Complaint-file establishment, Manufacturer
Record published	2016-09-09
Record revised	2025-07-01 (version 7)

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 15 to 30 °C
Distribution end date	2025-04-29

Catalogue Numbers

Catalogue numbers for Aries® Flu A/B & RSV Assay
Catalogue number	Size	Status
50-10020		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge	Nanosphere, Inc.	1
SilarisTM Influenza A&B Starter Pack	Mesa Biotech, Inc.	1
cobas® Influenza A/B &RSV Quality Control Kit for use on the cobas® Liat® System	Roche Molecular Systems, Inc.	1
Respiratory Pathogens Flex (RP Flex) Extraction Tray	Nanosphere, Inc.	1
Silaris Dock	Mesa Biotech, Inc.	1
Respiratory Pathogens Flex (RP Flex) Amplification Tray	Nanosphere, Inc.	1
cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System	Roche Molecular Systems, Inc.	1

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason
2019-02-20	Class II	Process control	Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could

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.