Gold Standard Diagnostics Is-EBV-VCA IgG Test Kit 720-600

GUDID B3507206000

Gold Standard Diagnostics Is-EBV-VCA IgG Test Kit

Gold Standard Diagnostics Corporation

Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: B3507206000
• NIH Device Record Key: fcb403df-5615-4189-b69e-7ad8819e2dd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gold Standard Diagnostics Is-EBV-VCA IgG Test Kit
• Version Model Number: 720-600
• Catalog Number: 720-600
• 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	B3507206000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981812

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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• B35000500CLR0 - Bolt (CLIA): 2023-11-08 Bolt EIA-CLIA (refurbished)
• B35000500R0 - Bolt: 2023-11-08 Bolt EIA (refurbished)
• B350GSD011600DYE0 - AIX1000 Performance Check Dye Kit: 2023-09-21 AIX1000 Performance Check Dye Kit
• B350GSD0124500 - Performance Check Dye Kit: 2023-09-21 Performance Check Dye Kit
• B350GSD051600NC0 - RPR Non-Reactive Control: 2023-09-21 RPR Non-Reactive Control