Novocastra™

Basic Information

• Brand Name: Novocastra™
• Primary DI: 05055331302076
• Version / Model: RE7113-CE
• Catalog Number: RE7113
• Company Name: LEICA BIOSYSTEMS NEWCASTLE LTD
• Labeler DUNS: 397134693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-12
• Public Version: 1
• Public Version Date: 2021-03-22
• Public Version Status: New
• Public Device Record Key: efca6a98-1ca7-4857-b097-6004142e9d95

Device Description

The Novocastra™ Epitope Retrieval Solutions RE7113, RE7114, RE7116 and RE7119 are intended for Heat Induced Epitope Retrieval on formalin-fixed, paraffin-embedded tissue sections as part of an immunohistochemical procedure.

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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PPM	General Purpose Reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57770	Immunohistochemistry antigen retrieval reagent IVD	A substance or reactant intended to be used for the non-enzymatic retrieval of antigenic epitopes from biological tissues or clinical specimen, using an enzyme immunohistochemistry assay.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055331302076	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

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