DEVICE: BD Multitest (00382906629654)
Device Identifier (DI) Information
BD Multitest
662965
In Commercial Distribution
662965
Becton, Dickinson And Company
662965
In Commercial Distribution
662965
Becton, Dickinson And Company
Multitest IMK Kit 50 Tests US-IVD
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
61272 | Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple cell markers expressed on normal and/or aberrant mature lymphocytes [B lymphocytes, T lymphocytes and natural killer (NK) cells] in a clinical specimen, using a fluorescent activated cell sorting/flow cytometry (FACS/Flow) method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GKZ | Counter, differential cell |
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 |
---|
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
eb6f43fe-4209-471e-a359-ec14d617d080
October 22, 2024
6
January 14, 2019
October 22, 2024
6
January 14, 2019
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