hCG Extended Range AccuBind ELISA Test System - 192 Wells (UDI 8825-300)
Manufactured by MONOBIND, INC.
Device Regulatory Overview
The hCG Extended Range AccuBind ELISA Test System - 192 Wells (Model/Catalog Number: 8825-300) is a medical device manufactured by MONOBIND, INC.. This product is indexed under FDA Product Code / Category Classification DHA within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 8825-300
- Product Code / EMDN
- DHA
- Device Name
- Database Sync Date
- 2026-08-09 09:31:26
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 hCG Extended Range AccuBind ELISA Test System - 192 Wells?
The registered manufacturer of record for hCG Extended Range AccuBind ELISA Test System - 192 Wells is MONOBIND, INC..
What is the Primary UDI-DI identifier for hCG Extended Range AccuBind ELISA Test System - 192 Wells?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 8825-300.
What classification code is assigned to this device?
This device is registered under product classification code DHA.
Similar Classification Devices (DHA)
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint