FITC Anti-Rabies Monoclonal Globulin

Basic Information

• Brand Name: FITC Anti-Rabies Monoclonal Globulin
• Primary DI: 00850212007003
• Version / Model: 800-092
• Company Name: FUJIREBIO DIAGNOSTICS, INC.
• Labeler DUNS: 079291908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 3
• Public Version Date: 2020-07-15
• Public Version Status: Update
• Public Device Record Key: c26056a8-9807-474a-a39f-c8fefdf7c213

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• 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
GOI	Antiserum, Fluorescent, Rabies Virus	Microbiology	866.3460	2

GMDN Terms

Code	Name	Definition	Implantable	Status
50182	Rabies virus antigen IVD, antibody	One or multiple immunoglobulins with the capability of binding to specific antigenic determinants intended to be used for the qualitative and/or quantitative detection of antigens from Rabies virus in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850212007003	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size Type = Tests per Kit; Size Unit = 100; Unit of Measure = Tests

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius