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.

BD FACSuite

Name: BD FACSuite
Brand: BD FACSuite

BD FACSuite™ Clinical BD Multitest™ 4-Color Assays v1.0

Registry build 21.09.26

1manufacturer

5catalogue numbers in this listing

2510(k) clearances naming this product code

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 BD FACSuite
Listed by	Becton, Dickinson AND Company, United States
FDA product code	OYE
Device type	Flow Cytometric Reagents And Accessories.
Device class	Class 2
Regulation	21 CFR 864.5220
Establishment	Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer
Record published	2022-07-15
Record revised	2024-10-22 (version 9)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number
Storage	Special storage condition: Room Temperature

Catalogue Numbers

Catalogue numbers for BD FACSuite
Catalogue number	Size	Status
665006		In distribution
663005		In distribution
663003		In distribution
663007		In distribution
665732		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 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
DxFLEX	Beckman Coulter, Inc.	1

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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K201814	2020-09-28
K170974	2017-07-03

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.