MHC Dextramer WD05109A PE 50

GUDID 05714183000133

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 and have specificity for the displayed peptide VGAVGVGK derived from KRAS. 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.

Immudex ApS

T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

• Primary Device ID: 05714183000133
• NIH Device Record Key: bbf5bfd6-7bc5-4b41-990b-78866259600d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MHC Dextramer
• Version Model Number: HLA-A*1101 / VVGAVGVGK / PE
• Catalog Number: WD05109A PE 50
• Company DUNS: 312388361
• Company Name: Immudex ApS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com
• Phone: +17037664688
• Email: customer@immudex.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C in the dark

Device Identifiers

Device Issuing Agency	Device ID
GS1	05714183000133 [Primary]

FDA Product Code

• MVU: Reagents, Specific, Analyte

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-18
• Device Publish Date: 2023-12-08

On-Brand Devices [MHC Dextramer]

• 05714183000133: Analyte specific reagent. Analytical and performance characteristics are not established. MHC De
• 05714183000126: Analyte specific reagent. Analytical and performance characteristics are not established. MHC De