gudid
Primary ID: 816030100
Coombscell-E (UDI 816030100)
Manufactured by Bio-Rad Medical Diagnostics GmbH
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Coombscell-E - Primary ID 816030100
Device Regulatory Overview
The Coombscell-E (Model/Catalog Number: 816030100) is a medical device manufactured by Bio-Rad Medical Diagnostics GmbH. This product is indexed under FDA Product Code / Category Classification KSF within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 816030100
- Product Code / EMDN
- KSF
- Device Name
- IgG-coated red blood cells for the control of antiglobulin test; 10ml
- Database Sync Date
- 2026-08-09 09:48:49
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 Coombscell-E?
The registered manufacturer of record for Coombscell-E is Bio-Rad Medical Diagnostics GmbH.
What is the Primary UDI-DI identifier for Coombscell-E?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 816030100.
What classification code is assigned to this device?
This device is registered under product classification code KSF.
Similar Classification Devices (KSF)
Other Devices by Bio-Rad Medical Diagnostics GmbH
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