DEVICE: Mono Mo A-Hu CD4/RPE, Cl MT310 (05700572028444)
Device Identifier (DI) Information
Mono Mo A-Hu CD4/RPE, Cl MT310
R0805
In Commercial Distribution
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
R0805
In Commercial Distribution
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Monoclonal Mouse Anti-Human CD4/RPE, Clone MT310
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? |
---|---|---|---|---|
56928 | CD4 cell marker IVD, antibody |
One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of CD4 cell marker in a clinical specimen.
|
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 |
---|
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Special Storage Condition, Specify: Keep away from sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 1 Milliliter |
Device Record Status
fc7d7aae-ea1c-44ba-ba41-beea73000430
December 07, 2020
7
September 16, 2016
December 07, 2020
7
September 16, 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
[?]
+4544859500
dako.dkregulatory@agilent.com
dako.dkregulatory@agilent.com