gudid
Primary ID: 816065100
Biotestcell Pool (UDI 816065100)
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 Pool - Primary ID 816065100
Device Regulatory Overview
The Biotestcell Pool (Model/Catalog Number: 816065100) 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
- 816065100
- Product Code / EMDN
- N/A
- Device Name
- Reagent Red Blood Cells; 3.0 - 3.4%; pooled cells for use in detection of unexpected antibodies with TANGO instruments; 10ml
- Database Sync Date
- 2026-08-09 09:48:49
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Biotestcell Pool?
The registered manufacturer of record for Biotestcell Pool is Bio-Rad Medical Diagnostics GmbH.
What is the Primary UDI-DI identifier for Biotestcell Pool?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 816065100.
What classification code is assigned to this device?
This device is registered under product classification code .
Similar Classification Devices ()
Other Devices by Bio-Rad Medical Diagnostics GmbH
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint