Gold Standard Diagnostics Borrelia burgdorferi B31 GSD01-1019

GUDID B350GSD0110190

Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit

GOLD STANDARD DIAGNOSTICS CORP.

Borrelia burgdorferi total antibody IVD, kit, immunoblot

• Primary Device ID: B350GSD0110190
• NIH Device Record Key: 20937b1c-0573-440e-8aee-45a6b164741b
• Commercial Distribution Discontinuation: 2018-03-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Gold Standard Diagnostics Borrelia burgdorferi B31
• Version Model Number: GSD01-1019
• Catalog Number: GSD01-1019
• Company DUNS: 790524891
• Company Name: GOLD STANDARD DIAGNOSTICS CORP.
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B350GSD0110190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113846

FDA Product Code

• LSR: Reagent, Borrelia Serological Reagent

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: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [Gold Standard Diagnostics Borrelia burgdorferi B31]

• B350GSD1010230: Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - 10 Pack
• B350GSD0410230: Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - Bulk Pack
• B350GSD0410220: Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit - Bulk Pack
• B350GSD0110190: Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit