AccessGUDID - DEVICE: MHC Dextramer (05714183000133)

GUDID

Device Identifier (DI) Information

Brand Name: MHC Dextramer
Version or Model: HLA-A*1101 / VVGAVGVGK / PE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: WD05109A PE 50
Company Name: Immudex ApS

Primary DI Number: 05714183000133
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312388361 *Terms of Use

Device Description: 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Public Device Record Key: bbf5bfd6-7bc5-4b41-990b-78866259600d
Public Version Date: May 17, 2024
Public Version Number: 2
DI Record Publish Date: December 08, 2023