DEVICE: BD Tritest™ (00382903403813)
Device Identifier (DI) Information
BD Tritest™
340381
In Commercial Distribution
340381
BECTON, DICKINSON AND COMPANY
340381
In Commercial Distribution
340381
BECTON, DICKINSON AND COMPANY
Tritest CD3 FITC/CD19 PE/CD45 PerCP IVD
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GKZ | Counter, differential cell |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K970742 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
359282d5-20be-49be-b5c9-14c0a971bc09
July 06, 2018
3
June 08, 2016
July 06, 2018
3
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