FDA.reportPublic FDA data

CMV Dextramer

Primary DI
05714183000089
Brand
CMV Dextramer
Company
Immudex ApS
Model
HLA-B*0702 / TPRVTGGGAM / PE
Catalog number
WH02136A PE 50
Device description
Analyte specific reagent. Analytical and performance characteristics are not established.CMV Dextramer reagents react with T cell receptors on human CD8+ T cells restricted by the HLA allele of the Dextramer and specific for the CMV peptide displayed.CMV Dextramers comprise dextran polymer backbone carrying multiple fluorochrome molecules (PE) and multiple MHC-peptide complexes displaying a peptide epitope from a CMV antigen. CMV Dextramer reagents are provided in liquid form in volumes of 0,5 ml in buffer containing 1% bovine serum albumin (BSA) and 15 mmol/L NaN, pH 7.2.
Published
2022-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
05714183000089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714183000089057141830000895714183000089

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

Contacts#

Phone, Email table
PhoneEmail
+1 703 766 4688customer@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
05714183000126MHC DextramerHLA-A*1101 / VVGAVGVGK / APCWD05109A AP 502023-12-08
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810034704399FITC anti-human Ki-67BIOLEGEND, INC.MVU2026-09-04
00810034704481PE anti-human CD366BIOLEGEND, INC.MVU2026-09-04
00810034703170PerCP anti-human CD61BIOLEGEND, INC.MVU2026-08-07
03661540953170DSQ Alert HT Adenovirus Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953187DSQ Alert HT Adenovirus Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953217DSQ Alert Hepatitis E Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953224DSQ Alert Hepatitis E Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953279DSQ Alert Mycoplasma pneumoniae Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953286DSQ Alert Mycoplasma pneumoniae Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
00810034704252FITC anti-human TNF-AlphaBIOLEGEND, INC.MVU2026-07-28
00810034704320PE anti-human IL-2BIOLEGEND, INC.MVU2026-07-28
00810227730211Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429820Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429837Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429844Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429851Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00810227730006Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730013Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730020Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730037Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429967Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429974Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429981Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429998Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730044Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730051Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730068Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730136Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730143Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730150Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21