gudid
Primary ID: K80C-4M
K-ASSAY hs-CRP Control (UDI K80C-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 hs-CRP Control - Primary ID K80C-4M
Device Regulatory Overview
The K-ASSAY hs-CRP Control (Model/Catalog Number: K80C-4M) is a medical device manufactured by KAMIYA BIOMEDICAL COMPANY, LLC. This product is indexed under FDA Product Code / Category Classification DCK within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- K80C-4M
- Product Code / EMDN
- DCK
- Device Name
- For use as a consistent test sample of known concentration for monitoring assay conditions for C-reactive protein (CRP).
- Database Sync Date
- 2026-08-09 09:40:11
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of K-ASSAY hs-CRP Control?
The registered manufacturer of record for K-ASSAY hs-CRP Control is KAMIYA BIOMEDICAL COMPANY, LLC.
What is the Primary UDI-DI identifier for K-ASSAY hs-CRP Control?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is K80C-4M.
What classification code is assigned to this device?
This device is registered under product classification code DCK.
Similar Classification Devices (DCK)
Other Devices by KAMIYA BIOMEDICAL COMPANY, LLC
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