gudid
Primary ID: 816020100
Biotestcell-I 8 (UDI 816020100)
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 Biotestcell-I 8 - Primary ID 816020100
Device Regulatory Overview
The Biotestcell-I 8 (Model/Catalog Number: 816020100) is a medical device manufactured by Bio-Rad Medical Diagnostics GmbH. This product is indexed under FDA Product Code / Category Classification within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 816020100
- Product Code / EMDN
- N/A
- Device Name
- Reagent Red Blood Cells; 3.0 - 3.4%; for use in identification of unexpected antibodies with TANGO instruments and by tube test; 8x4ml
- 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 Biotestcell-I 8?
The registered manufacturer of record for Biotestcell-I 8 is Bio-Rad Medical Diagnostics GmbH.
What is the Primary UDI-DI identifier for Biotestcell-I 8?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 816020100.
What classification code is assigned to this device?
This device is registered under product classification code .
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