FDA.reportPublic FDA data

Dextramer CMV Kit

Primary DI
05714183000010
Brand
Dextramer CMV Kit
Company
Immudex ApS
Model
CX02
Catalog number
CX02
Device description
The Dextramer® CMV Kit comprises :;HLA-A*0101 / VTEHDTLLY / PE; HLA-A*0201 / NLVPMVATV / PE; HLA-B*0702 / TPRVTGGGAM / PE; HLA-B*0801 / ELRRKMMYM / PE;HLA-B*3501 / IPSINVHHY / PE Negative control / PE; Anti-CD8/FITC; Anti-CD3/PerCP; Anti-CD4/PE The Dextramer CMV Kit accurately enumerates CMV-specific T cells in blood samples. Dextramer® CMV Kit is a semi-quantitative assay intended for the identification and enumeration of cytomegalovirus (CMV)-specific CD8+ T cells in anticoagulated (Na Heparin) whole blood specimens by flow cytometry. Dextramer® CMV Kit is indicated for assessment of CMV-specific immune status and risk of CMV reactivation in adult human stem cell transplant patients following immunosuppression and used in conjunction with other laboratory and clinical findings. The kit cannot be used to measure CMV infection or disease.
Published
2018-10-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GKZCounter, Differential Cell

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKZCounter, Differential CellHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153538000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153538000Dextramer CMV KitImmudex Aps2017-03-02GKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05714183000010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714183000010057141830000105714183000010

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
+1 703 766 4688customer@immudex.com

Regulatory Flags#

DUNS number
312388361
Device count
1
Kit
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
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

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