FDA.reportPublic FDA data

Anti Pan Cytokeratin Antibody

Primary DI
B766U311000
Brand
Anti Pan Cytokeratin Antibody
Company
INCELLDX, INC.
Model
U31100
Catalog number
U31100
Device description
Anti Pan Cytokeratin Antibody is a mouse monoclonal antibody to cytokeratin epitopes [C-11] conjugated with Phycoerythrin (PE).
Published
2020-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
B766U311000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cytokeratin 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 one or multiple cytokeratin subtype(s) in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume100Microliter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
833074623
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B766C313150HPV E6, E7 mRNA Probe, Ready to UseC313152023-02-28
B766C310500Anti PD-L1 AntibodyC31050C310502020-02-05
B766U310750Anti CD45 AntibodyU31075U310752020-02-05
B766C311000HPV E6, E7 mRNA Probe C31100C311002019-09-19

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