GUDIDData
gudid Primary ID: KAI-084C

K-ASSAY CRP (3) Calibrator E (UDI KAI-084C)

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 CRP (3) Calibrator E - Primary ID KAI-084C

Device Regulatory Overview

The K-ASSAY CRP (3) Calibrator E (Model/Catalog Number: KAI-084C) 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
KAI-084C
Product Code / EMDN
DCK
Device Name
For the calibration of the K-ASSAY CRP (3) assay.
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 CRP (3) Calibrator E?

The registered manufacturer of record for K-ASSAY CRP (3) Calibrator E is KAMIYA BIOMEDICAL COMPANY, LLC.

What is the Primary UDI-DI identifier for K-ASSAY CRP (3) Calibrator E?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is KAI-084C.

What classification code is assigned to this device?

This device is registered under product classification code DCK.

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