GUDIDData
gudid Primary ID: 10275-300

Monobind AccuLite Free B-hCG XR CLIA Kit - 192 Wells (UDI 10275-300)

Manufactured by MONOBIND, INC.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Monobind AccuLite Free B-hCG XR CLIA Kit - 192 Wells - Primary ID 10275-300

Device Regulatory Overview

The Monobind AccuLite Free B-hCG XR CLIA Kit - 192 Wells (Model/Catalog Number: 10275-300) 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
10275-300
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
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of Monobind AccuLite Free B-hCG XR CLIA Kit - 192 Wells?

The registered manufacturer of record for Monobind AccuLite Free B-hCG XR CLIA Kit - 192 Wells is MONOBIND, INC..

What is the Primary UDI-DI identifier for Monobind AccuLite Free B-hCG XR CLIA Kit - 192 Wells?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 10275-300.

What classification code is assigned to this device?

This device is registered under product classification code DHA.

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