Novocastra™

Basic Information

• Brand Name: Novocastra™
• Primary DI: 05055331300034
• Version / Model: ZAP-70-L-CE
• Catalog Number: NCL-L-ZAP-70
• Company Name: LEICA BIOSYSTEMS NEWCASTLE LTD
• Labeler DUNS: 397134693
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-23
• Public Version: 2
• Public Version Date: 2023-11-20
• Public Version Status: Update
• Public Device Record Key: d7ac6327-4a2a-447d-b26c-b0dd5fd53226
• Distribution End Date: 2023-11-17

Device Description

NCL-L-ZAP-70 is intended for the qualitative identification by light microscopy of ZAP-70 molecules in paraffin sections.

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
NJT	Immunohistochemistry Reagents And Kits	Hematology	864.1860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57715	Zeta chain associated protein kinase 70 (ZAP-70) 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 zeta chain associated protein kinase 70 (ZAP-70) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055331300034	GS1

Customer Contacts

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

Storage Conditions

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