Pathfinder 30491

GUDID 00847865001472

HSV Type 2 Monoclonal Antibody

Bio-RAD Laboratories, Inc.

Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, reagent

• Primary Device ID: 00847865001472
• NIH Device Record Key: 75540458-fa3f-4655-b5ab-50e0f66be761
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pathfinder
• Version Model Number: 30491
• Catalog Number: 30491
• Company DUNS: 844766394
• Company Name: Bio-RAD Laboratories, 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: false
• Device Combination Product: false
• Single Use: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)224-6723
• Email: TechSupport.USSD-Redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD-Redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD-Redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD-Redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD-Redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD-Redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD-Redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD-Redmond@bio-rad.com

Device Dimensions

• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Device Size Text, specify: 0
• Total Volume: 5 Milliliter
• Device Size Text, specify: 0
• Total Volume: 5 Milliliter
• Device Size Text, specify: 0
• Total Volume: 5 Milliliter
• Device Size Text, specify: 0
• Total Volume: 5 Milliliter
• Device Size Text, specify: 0
• Total Volume: 5 Milliliter
• Device Size Text, specify: 0
• Total Volume: 5 Milliliter
• Device Size Text, specify: 0
• Total Volume: 5 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847865001472 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K852125

FDA Product Code

• GQL: Antisera, fluorescent, herpesvirus hominis 1,2

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-23
• Device Publish Date: 2016-09-12

On-Brand Devices [Pathfinder]

• 00847865012768: Herpes Simplex Virus 1 and 2, 4 Well Slides
• 00847865001489: HSV Type 1 and 2, 2 Well Slides
• 00847865001472: HSV Type 2 Monoclonal Antibody
• 00847865001465: Herpes Simplex Virus Types 1 and 2 Direct Antigen Detection System
• 00847865001403: Pathfinder Mounting Media
• 00847865001212: HSV Type 1 Monoclonal Antibody
• 00847865012775: Pathfinder Chlamydia trachomatis 2 Well Direct Specimen Control Slides
• 00847865001441: Pathfinder Chlamydia trachomatis Direct Specimen Monoclonal Antibody
• 00847865001434: Pathfinder Chlamydia trachomatis Direct Specimen System
• 00847865001427: Pathfinder Chlamydia Culture Confirmation System
• 00847865001410: Pathfinder Chlamydia trachomatis Specimen Slides, 1 well