gudid Primary ID: KAI-018C

K-ASSAY Lp(a) Calibrator (UDI KAI-018C)

Manufactured by KAMIYA BIOMEDICAL COMPANY, LLC

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The K-ASSAY Lp(a) Calibrator (Model/Catalog Number: KAI-018C) is a medical device manufactured by KAMIYA BIOMEDICAL COMPANY, LLC. This product is indexed under FDA Product Code / Category Classification JIS within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: KAI-018C
Product Code / EMDN: JIS
Device Name: For the calibration of the K-ASSAY Lp(a) assay.
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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Frequently Asked Questions

Who is the primary manufacturer of K-ASSAY Lp(a) Calibrator?

The registered manufacturer of record for K-ASSAY Lp(a) Calibrator is KAMIYA BIOMEDICAL COMPANY, LLC.

What is the Primary UDI-DI identifier for K-ASSAY Lp(a) Calibrator?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is KAI-018C.

What classification code is assigned to this device?

This device is registered under product classification code JIS.

Similar Classification Devices (JIS)

Other Devices by KAMIYA BIOMEDICAL COMPANY, LLC

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