Tissue-Tek Genie®

Basic Information

• Brand Name: Tissue-Tek Genie®
• Primary DI: 00615233001986
• Version / Model: 8385-C010
• Catalog Number: 8385-C010
• Company Name: SAKURA FINETEK U.S.A., INC.
• Labeler DUNS: 179135769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-01
• Public Version: 1
• Public Version Date: 2020-01-09
• Public Version Status: New
• Public Device Record Key: 01bd77b1-50ef-4e1a-8f37-853c6678a247

Device Description

anti-IgM Rabbit Polyclonal Antibody, 10 RTU capsules

Device Characteristics

• Single Use: Yes
• 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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
57307	Polyvalent human immunoglobulin antibody 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 all classes of human immunoglobulin (i.e, IgA, IgE, IgD, IgG, IgM) and/or specific immunoglobulin chains in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615233001986	GS1

Customer Contacts

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