ThunderBolt EIA (CLIA) (UDI B35000300CL0)
Manufactured by Gold Standard Diagnostics, LLC
Device Regulatory Overview
The ThunderBolt EIA (CLIA) (Model/Catalog Number: 00300-CL) is a medical device manufactured by Gold Standard Diagnostics, LLC. This product is indexed under FDA Product Code / Category Classification W0201020101 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 00300-CL
- Product Code / EMDN
- W0201020101
- Device Name
- ThunderBolt EIA (CLIA)
- Database Sync Date
- 2026-08-09 17:06:56
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of ThunderBolt EIA (CLIA)?
The registered manufacturer of record for ThunderBolt EIA (CLIA) is Gold Standard Diagnostics, LLC.
What is the Primary UDI-DI identifier for ThunderBolt EIA (CLIA)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is B35000300CL0.
What classification code is assigned to this device?
This device is registered under product classification code W0201020101.
Similar Classification Devices (W0201020101)
Other Devices by Gold Standard Diagnostics, LLC
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