Bolt 00500R

GUDID B35000500R0

Bolt EIA (refurbished)

Gold Standard Diagnostics Corporation

Enzyme immunoassay (EIA) analyser IVD

• Primary Device ID: B35000500R0
• NIH Device Record Key: e2b846c2-4d65-49e0-817c-1ff43d141066
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bolt
• Version Model Number: 00500R
• Catalog Number: 00500R
• Company DUNS: 790524891
• Company Name: Gold Standard Diagnostics Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B35000500R0 [Primary]

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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: 2023-11-08
• Device Publish Date: 2023-10-31

On-Brand Devices [Bolt]

• B350005000: Bolt EIA
• B35000500R0: Bolt EIA (refurbished)