Genemed®

Basic Information

• Brand Name: Genemed®
• Primary DI: 00615233006325
• Version / Model: 60-0088-7
• Catalog Number: 60-0088-7
• 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: 2019-12-28
• Public Version: 1
• Public Version Date: 2020-01-06
• Public Version Status: New
• Public Device Record Key: 8d8c2c19-49cc-4902-8c44-9ac558efe447

Device Description

anti-AFP Rabbit Polyclonal Antibody, Ready-To-Use, 7 mL

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: 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
56770	Alpha-fetoprotein (AFP) 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 alpha-fetoprotein (AFP) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615233006325	GS1

Customer Contacts

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