FDA.reportPublic FDA data

CD45-OC515™

Primary DI
08436548983468
Brand
CD45-OC515™
Company
CYTOGNOS SL
Model
CYT-45OC-A
Catalog number
CYT-45OC-A
Device description
CD45-OC515™
Published
2022-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08436548983468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436548983468084365489834688436548983468

GMDN Terms#

Term, Definition table
TermDefinition
CD45 leukocyte common antigen cell marker IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of CD45 leukocyte common antigen cell marker in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
563942887
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08436548983413CD38-multi-epitope-FITCCYT-38F2-500-ACYT-38F2-500-A2023-01-17
08436548984946CD45-APC-C750™CYT-45AC750-500-ACYT-45AC750-500-A2023-01-17
08436548983352CD38-multi-epitope-FITCCYT-38F2-ACYT-38F2-A2022-09-23
08436548983369CD38-FITCCYT-38F-ACYT-38F-A2022-09-23
08436548983376CD38-APC-C750™CYT-38AC750-ACYT-38AC750-A2022-09-23
08436548983390CD138-PE CYT-138PE4-ACYT-138PE4-A2022-09-23
08436548983406CD19-PE-Cyanine7 CYT-19C4-ACYT-19C4-A2022-09-23
08436548983437CD3-APC-C750™CYT-3AC750-ACYT-3AC750-A2022-09-23
08436548983444CD45-APC-C750™CYT-45AC750-ACYT-45AC750-A2022-09-23
08436548983475CD56-PECYT-56PE-ACYT-56PE-A2022-09-23
08436548983499CD81-APC-C750™ CYT-81AC750-ACYT-81AC750-A2022-09-23
08436548983505Kappa-APCCYT-KAPPAP-ACYT-KAPPAP-A2022-09-23
08436548983512Lambda-APC-C750™CYT-LAC750-ACYT-LAC750-A2022-09-23
08436548983529MPO-FITC CYT-MPOF3-ACYT-MPOF3-A2022-09-23
08436548983543CD15-FITC CYT-15F4-ACYT-15F4-A2022-09-23
08436548983659Lambda-PECYT-LAMBPE-ACYT-LAMBPE-A2022-09-23

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