FDA.reportPublic FDA data

Anti Pan Cytokeratin Antibody

Primary DI
B766U311000
Brand
Anti Pan Cytokeratin Antibody
Company
HealthBio, 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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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 Volume0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
833074623
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G882C313150HPV E6, E7 mRNA Probe, Ready to UseC313152026-07-01
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 ProbeC31100C311002019-09-19

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