DEVICE: Control-HLA-DR (pos.) (07611969953196)
Device Identifier (DI) Information
Control-HLA-DR (pos.)
824110
Not in Commercial Distribution
824110
Bio-Rad Medical Diagnostics GmbH
824110
Not in Commercial Distribution
824110
Bio-Rad Medical Diagnostics GmbH
Control-HLA-DR (pos.) (lyo.) 0,5 ml
For use in the microlymphocytotoxicity test
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
56400 | HLA class I & II antigen tissue typing IVD, control |
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple HLA class I and II antigens in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MZI | Test,Qualitative,For Hla,Non-Diagnostic |
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 |
---|
No Device Sizes |
Device Record Status
64311376-763e-4d01-902c-044965b35a9b
January 19, 2024
4
July 01, 2015
January 19, 2024
4
July 01, 2015
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
[?]
800-224-6723
techsupport.bmd@bio-rad.com
techsupport.bmd@bio-rad.com