K-ASSAY Hemoglobin A1c Control (UDI K29C-4M)
Manufactured by KAMIYA BIOMEDICAL COMPANY, LLC
Device Regulatory Overview
The K-ASSAY Hemoglobin A1c Control (Model/Catalog Number: K29C-4M) is a medical device manufactured by KAMIYA BIOMEDICAL COMPANY, LLC. This product is indexed under FDA Product Code / Category Classification LCP within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- K29C-4M
- Product Code / EMDN
- LCP
- Device Name
- For use as a consistent test sample of known concentration for monitoring assay conditions for hemoglobin A1c.
- 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 Hemoglobin A1c Control?
The registered manufacturer of record for K-ASSAY Hemoglobin A1c Control is KAMIYA BIOMEDICAL COMPANY, LLC.
What is the Primary UDI-DI identifier for K-ASSAY Hemoglobin A1c Control?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is K29C-4M.
What classification code is assigned to this device?
This device is registered under product classification code LCP.
Similar Classification Devices (LCP)
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