DEVICE: MHC Dextramer (05714183000133)
Device Identifier (DI) Information
MHC Dextramer
HLA-A*1101 / VVGAVGVGK / PE
In Commercial Distribution
WD05109A PE 50
Immudex ApS
HLA-A*1101 / VVGAVGVGK / PE
In Commercial Distribution
WD05109A PE 50
Immudex ApS
Analyte specific reagent. Analytical and performance characteristics are not established. MHC Dextramer® reagent recognizing T cell receptors displayed on surface of human T cells restricted by HLA-A*11:01 with specificity for the KRAS G12V neopeptide: VVGAVGVGK. MHC Dextramer reagents consist of a dextran polymer backbone carrying an optimized number of MHC-peptide complexes and fluorochrome molecules (PE). MHC Dextramer reagents are provided in buffer containing 1% bovine serum albumin (BSA) and 15 mM NaN3, pH 7.2.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
57631 | T lymphocyte 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 T lymphocytes 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 |
---|---|
MVU | Reagents, Specific, Analyte |
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: 2-8°C in the dark |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
bbf5bfd6-7bc5-4b41-990b-78866259600d
May 17, 2024
2
December 08, 2023
May 17, 2024
2
December 08, 2023
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
[?]
+17037664688
customer@immudex.com
customer@immudex.com