ThunderBolt EIA (CLIA) 00300-CLR

GUDID B35000300CLR0

ThunderBolt EIA-CLIA (refurbished)

Gold Standard Diagnostics Corporation

Enzyme immunoassay (EIA) analyser IVD

• Primary Device ID: B35000300CLR0
• NIH Device Record Key: 5690960a-4d56-4986-8830-314a99998c7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThunderBolt EIA (CLIA)
• Version Model Number: 00300-CLR
• Catalog Number: 00300-CLR
• 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	B35000300CLR0 [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 [ThunderBolt EIA (CLIA)]

• B35000300CL0: ThunderBolt EIA-CLIA
• B35000300CLR0: ThunderBolt EIA-CLIA (refurbished)