Anti Pan Cytokeratin Antibody

Basic Information

• Brand Name: Anti Pan Cytokeratin Antibody
• Primary DI: B766U311000
• Version / Model: U31100
• Catalog Number: U31100
• Company Name: INCELLDX, INC.
• Labeler DUNS: 833074623
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-05
• Public Version: 1
• Public Version Date: 2020-02-13
• Public Version Status: New
• Public Device Record Key: 63501d23-086d-44b4-9e54-73125f80ead7

Device Description

Anti Pan Cytokeratin Antibody is a mouse monoclonal antibody to cytokeratin epitopes [C-11] conjugated with Phycoerythrin (PE).

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MVU	Reagents, Specific, Analyte	Pathology	864.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57079	Cytokeratin IVD, antibody	One 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B766U311000	HIBCC

Device Sizes

Type	Value	Unit	Text
Total Volume	100	Microliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius