ThunderBolt EIA (CLIA) 00300CL

GUDID B35000300CL0

ThunderBolt EIA-CLIA

Gold Standard Diagnostics Corporation

Enzyme immunoassay (EIA) analyser IVD

• Primary Device ID: B35000300CL0
• NIH Device Record Key: 971afbb0-f130-4587-b913-1537cb83dd40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThunderBolt EIA (CLIA)
• Version Model Number: 00300-CL
• Catalog Number: 00300CL
• 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	B35000300CL0 [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: 2022-10-03
• Device Publish Date: 2022-09-24

On-Brand Devices [ThunderBolt EIA (CLIA)]

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