FDA.reportPublic FDA data

Dynabeads™ HLA Cell Prep™ II

Primary DI
10190302006835
Brand
Dynabeads™ HLA Cell Prep™ II
Company
THERMO FISHER SCIENTIFIC BALTICS UAB
Model
21903
Device description
DYNABEADS HLA CELL PREP II
Published
2018-07-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JCFLYMPHOCYTE SEPARATION MEDIUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCFLymphocyte Separation MediumHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190302006835PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019030200683510190302006835

GMDN Terms#

Term, Definition table
TermDefinition
B lymphocyte magnetic separation reagent IVDA substance or reactant intended to be used on clinical specimens for the isolation of B-lymphocytes from a white cell preparation using magnetic beads to achieve component separation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
644884074
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190302018241MagMAX™ Viral/Pathogen II Nucleic Acid Isolation KitA483832023-03-22
10190302006842Dynabeads™ HLA Cell Prep™ II219042018-07-03
10190302015769MagMAX™ MVP II BINDING BEADSA483812022-10-26
10190302015776MagMAX™ Viral/Pathogen Binding SolutionA42359LT2022-10-26
10190302015783MagMAX™ Viral/Pathogen Wash SolutionA42360LT2022-10-26
10190302015790MagMAX™ Viral/Pathogen Proteinase KA42363LT2022-10-26
10190302015806MagMAX™ Viral/Pathogen Elution BufferA42364LT2022-10-26
10190302019170MagMAX™ Dx Viral/Pathogen NA Isolation Kit, 2000 RXNA527352024-02-05
10190302019187MagMAX™ Dx Viral/Pathogen NA Isolation Kit, 600 RXNA527362024-02-05

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05407010122756X-VIVO 15 w/o PR and Gentamicine 10L bagLonza VerviersJCF2022-09-12
05407010122817TheraPEAK™ X-VIVO™ 15 w REC TRANSF 1LLonza VerviersJCF2022-09-12
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05407010122831X-VIVO 10 w/o Gentamycin w/o PR, 1LLonza VerviersJCF2022-09-12