Gold Standard Diagnostics Is-EBV-VCA IgM Test Kit 720-610

GUDID B3507206100

Gold Standard Diagnostics Is-EBV-VCA IgM Test Kit

Gold Standard Diagnostics Corporation

Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: B3507206100
• NIH Device Record Key: ace50ed7-7ac8-4797-a328-7b382475ac1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gold Standard Diagnostics Is-EBV-VCA IgM Test Kit
• Version Model Number: 720-610
• Catalog Number: 720-610
• Company DUNS: 790524891
• Company Name: Gold Standard Diagnostics Corporation
• 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: true
• OTC Over-The-Counter: false

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B3507206100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982352

FDA Product Code

• LSE: Epstein-Barr Virus, Other

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-15
• Device Publish Date: 2022-12-07

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