gudid
Primary ID: K73C-4M
K-ASSAY Insulin Control (UDI K73C-4M)
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-4M
Device Regulatory Overview
The K-ASSAY Insulin Control (Model/Catalog Number: K73C-4M) 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-4M
- 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
}
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 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-4M.
What classification code is assigned to this device?
This device is registered under product classification code JJX.
Similar Classification Devices (JJX)
Other Devices by KAMIYA BIOMEDICAL COMPANY, LLC
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint