Bio-Rad 12008531

GUDID 03610522051236

HSV Type 2 Specific IgG EIA Test Set

Bio-RAD Laboratories, Inc.

Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 03610522051236
• NIH Device Record Key: 13c9e4f1-81a2-4185-a4ad-e22681195d63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio-Rad
• Version Model Number: 12008531
• Catalog Number: 12008531
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03610522051236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152353

FDA Product Code

• MYF: Enzyme linked immunosorbent assay, herpes simplex virus, hsv-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: 2
• Public Version Date: 2020-01-23
• Device Publish Date: 2019-05-28

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• 00847865001786: Wash Solution Concentrate (30X), 15 x 120 mL
• 03610522051236: HSV Type 2 Specific IgG EIA Test Set
• 03610522051076: HSV Type 1 Specific IgG EIA Test Set