p120 Catenin, RMab

Basic Information

• Brand Name: p120 Catenin, RMab
• Primary DI: L502BSB2082
• Version / Model: Concentrate, 1 ml
• Catalog Number: BSB 2082
• Company Name: BIO SB, INC.
• Labeler DUNS: 102855447
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-01
• Public Version: 1
• Public Version Date: 2020-06-09
• Public Version Status: New
• Public Device Record Key: 45e22299-5713-44bf-9506-e88a234e8bff

Device Description

Anti-p120 Catenin is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• 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
NJT	Immunohistochemistry Reagents And Kits	Hematology	864.1860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57767	Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of primary antibodies directed at specific cellular markers in a clinical specimen, using an enzyme immunohistochemistry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	L502BSB2082	HIBCC