FITC Anti-Rabies Monoclonal Globulin

GUDID 00850212007003

FUJIREBIO US, INC.

Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody Rabies virus antigen IVD, antibody

• Primary Device ID: 00850212007003
• NIH Device Record Key: c26056a8-9807-474a-a39f-c8fefdf7c213
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FITC Anti-Rabies Monoclonal Globulin
• Version Model Number: 800-092
• Company DUNS: 029385775
• Company Name: FUJIREBIO US, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850212007003 [Primary]

FDA Product Code

• GOI: Antiserum, Fluorescent, Rabies Virus

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-16

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