GUDIDData
gudid Primary ID: K73C-2M

K-ASSAY Insulin Control (UDI K73C-2M)

Manufactured by KAMIYA BIOMEDICAL COMPANY, LLC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for K-ASSAY Insulin Control - Primary ID K73C-2M

Device Regulatory Overview

The K-ASSAY Insulin Control (Model/Catalog Number: K73C-2M) is a medical device manufactured by KAMIYA BIOMEDICAL COMPANY, LLC. This product is indexed under FDA Product Code / Category Classification JJX within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
K73C-2M
Product Code / EMDN
JJX
Device Name
For use as a consistent test sample of known concentration for monitoring assay conditions for Insulin.
Database Sync Date
2026-08-09 09:40:11

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 K-ASSAY Insulin Control?

The registered manufacturer of record for K-ASSAY Insulin Control is KAMIYA BIOMEDICAL COMPANY, LLC.

What is the Primary UDI-DI identifier for K-ASSAY Insulin Control?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is K73C-2M.

What classification code is assigned to this device?

This device is registered under product classification code JJX.

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