ThunderBolt EIA (CLIA) 00300-CLR

GUDID B35000300CLR0

ThunderBolt EIA-CLIA (refurbished)

Gold Standard Diagnostics Corporation

Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD 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)