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

Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge

Name: Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge
Brand: Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge

Catalogue number 20-006-024, listed by Nanosphere, Inc., United States, under Influenza A And Influenza B Multiplex Nucleic Acid Assay. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

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 Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge
Listed by	Nanosphere, Inc., 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
510(k)	K143653
Record published	2016-09-23
Record revised	2023-12-18 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C
Distribution end date	2019-12-05

Catalogue Numbers

Catalogue numbers for Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge
Catalogue number	Size	Status
20-006-024		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Aries® Flu A/B & RSV Assay	Luminex Corporation	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 Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Luminex Corporation	510(k) number	2020-10-30	Class II	Device Design	Potential for a false-negative result.	38,990
Luminex Corporation	510(k) number	2018-12-10	Class II	Component design/selection	No results/incorrect results due to failure of the hybridization heater.	1 system

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.