DEVICE: BD FACSCalibur (00382903429745)
Device Identifier (DI) Information
BD FACSCalibur
342974
In Commercial Distribution
342974
BECTON, DICKINSON AND COMPANY
342974
In Commercial Distribution
342974
BECTON, DICKINSON AND COMPANY
BD FACSCalibur™ Flow Cytometer
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
57839 | Flow cytometry analyser IVD |
An electrically-powered automated or semi-automated laboratory instrument intended to be used to count, examine and/or sort cells or microscopic particles in a clinical specimen (e.g., blood, urine). Detection of individual components is performed using an optical or electrical detection system based on physical or chemical characteristics, or by detecting immunological markers introduced to the sample during the preanalytical phase and bound via antigen-antibody reactions.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GKZ | Counter, differential cell |
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
ad8273a0-72ff-48cf-afef-607a65d3d6af
September 16, 2022
6
June 08, 2016
September 16, 2022
6
June 08, 2016
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