gudid
Primary ID: 25220
MONOLISA (UDI 25220)
Manufactured by Bio-RAD Laboratories, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for MONOLISA - Primary ID 25220
Device Regulatory Overview
The MONOLISA (Model/Catalog Number: 25220) is a medical device manufactured by Bio-RAD Laboratories, Inc.. This product is indexed under FDA Product Code / Category Classification LOM within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 25220
- Product Code / EMDN
- LOM
- Device Name
- MONOLISA Anti-HBs EIA 192 tests
- Database Sync Date
- 2026-08-09 09:48:17
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 MONOLISA?
The registered manufacturer of record for MONOLISA is Bio-RAD Laboratories, Inc..
What is the Primary UDI-DI identifier for MONOLISA?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 25220.
What classification code is assigned to this device?
This device is registered under product classification code LOM.
Similar Classification Devices (LOM)
Other Devices by Bio-RAD Laboratories, Inc.
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint