Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit GSD01-1027

GUDID B350GSD0110270

Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit

Gold Standard Diagnostics Corporation

Borrelia burgdorferi antigen IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: B350GSD0110270
• NIH Device Record Key: 9ad8ed12-66e8-4ac5-8fbb-31b383a461a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit
• Version Model Number: GSD01-1027
• Catalog Number: GSD01-1027
• 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: 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

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
HIBCC	B350GSD0110270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203289

FDA Product Code

• LSR: Reagent, Borrelia Serological Reagent

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: 2021-07-28
• Device Publish Date: 2021-07-20

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• B35000500R0 - Bolt: 2023-11-08 Bolt EIA (refurbished)
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