FDA.reportPublic FDA data

MHC Dextramer

Primary DI
05714183000126
Brand
MHC Dextramer
Company
Immudex ApS
Model
HLA-A*1101 / VVGAVGVGK / APC
Catalog number
WD05109A AP 50
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 (APC). MHC Dextramer reagents are provided in buffer containing 1% bovine serum albumin (BSA) and 15 mM NaN3, pH 7.2.
Published
2023-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05714183000126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714183000126057141830001265714183000126

GMDN Terms#

Term, Definition table
TermDefinition
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify002-8°C in the dark

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+17037664688customer@immudex.com

Regulatory Flags#

DUNS number
312388361
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05714183000133MHC DextramerHLA-A*1101 / VVGAVGVGK / PEWD05109A PE 502023-12-08
05714183000034CMV Dextramer HLA-A*0101 / VTEHDTLLY / PEWA02131A PE 502022-12-13
05714183000041CMV DextramerHLA-A*0201 / NLVPMVATV / PEWB02132A PE 502022-12-14
05714183000058CMV DextramerHLA-A*0301 / KLGGALQAK / PEWC02197A PE 502022-12-14
05714183000065CMV DextramerHLA-A*2402 / QYDPVAALF / PEWF02133A PE 502022-12-14
05714183000072CMV DextramerHLA-B*0702 / RPHERNGFTVL / PEWH02135A PE 502022-12-14
05714183000089CMV DextramerHLA-B*0702 / TPRVTGGGAM / PEWH02136A PE 502022-12-14
05714183000096CMV DextramerHLA-B*0801 / ELRRKMMYM / PEWI02137A PE 502022-12-14
05714183000102CMV DextramerHLA-B*3501 / IPSINVHHY / PEWK02138A PE 502022-12-14
05714183000119CMV DextramerNegative Dextramer / PENI03233A PE 502022-12-14
05714183000010Dextramer CMV KitCX02CX022018-10-08

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