DEVICE: BD FACSuite (00382906650061)
Device Identifier (DI) Information
BD FACSuite
665006
In Commercial Distribution
665006
Becton, Dickinson And Company
665006
In Commercial Distribution
665006
Becton, Dickinson And Company
Module Assay SCE FACSLyric US IVD
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
55858 | White blood cell count IVD, kit, cell count |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of the white blood cell (leukocyte) count and/or the differential of white cell types in a clinical specimen using a manual, semi-automated or automated cell count method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OYE | Flow cytometric reagents and accessories. |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Room Temperature |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
5021ab6f-1acd-4b34-b3e6-df7fed53ff1f
April 23, 2025
4
July 15, 2022
April 23, 2025
4
July 15, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(877)232-8995
BDBCustomerService@bd.com
BDBCustomerService@bd.com