What is FDA product code OYE?

To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level of protein expression. These characteristics may aid in the diagnosis of conditions such as immunodeficiency and cancer.

Hematology › Automated Hematology DevicesFlow Cytometric Reagents And Accessories.

Aquios Tetra-1 Panel

Name: Aquios Tetra-1 Panel
Brand: Aquios Tetra-1 Panel

AQUIOS Tetra-1 Panel CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code OYE
Manufacturer	City	Province	Registered as	Device types
Beckman Coulter Biotechnology (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Specification developer	2

Record

Regulatory record for Aquios Tetra-1 Panel
Listed by	Beckman Coulter Ireland Inc, Ireland
FDA product code	OYE
Device type	Flow Cytometric Reagents And Accessories.
Device class	Class 2
Regulation	21 CFR 864.5220
Establishment	Contract manufacturer, Specification developer, Manufacturer
Record published	2016-09-23
Record revised	2023-06-19 (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, manufacturing date

Catalogue Numbers

Catalogue numbers for Aquios Tetra-1 Panel
Catalogue number	Size	Status
B23533		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Navios EX	Beckman Coulter Ireland Inc	7
BD FACSuite	Becton, Dickinson AND Company	5
BD FACSLyric	Becton, Dickinson AND Company	4
FACSCanto	Becton, Dickinson AND Company	4
Navios Analysis Software	Beckman Coulter Ireland Inc	3
FACSuite	Becton, Dickinson AND Company	3
Flow Cytometric Reagents And Accessories.	Becton, Dickinson AND Company	3
BD FACSDiva	Becton, Dickinson AND Company	3
Navios	Beckman Coulter Ireland Inc	3
BD FACSDiva™	Becton, Dickinson AND Company	2
FACSVia	Becton, Dickinson AND Company	2
Navios tetra Software	Beckman Coulter Ireland Inc	1

Showing 12 of 20. All products under Flow Cytometric Reagents And Accessories.

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.