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

SilarisTM Influenza A&B Starter Pack

Name: SilarisTM Influenza A&B Starter Pack
Brand: SilarisTM Influenza A&B Starter Pack

The Silaris Starter Pack contains two (2) Silaris Influenza A&B kits and one (1) Silaris Dock for the purposes of starting up a clinical location.

Registry build 21.09.26

1manufacturer

1catalogue number

1510(k) clearance

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 SilarisTM Influenza A&B Starter Pack
Listed by	Mesa Biotech, 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)	K171641
Record published	2018-03-15
Record revised	2025-07-14 (version 4)

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 59 to 86 °F; Storage environment temperature 15 to 30 °C

Catalogue Numbers

Catalogue numbers for SilarisTM Influenza A&B Starter Pack
Catalogue number	Size	Status
1028		In distribution

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
Aries® Flu A/B & RSV Assay	Luminex Corporation	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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K171641	2018-02-06

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.