gudid
Primary ID: KAI-160
K-ASSAY hsCRP Reagent (UDI KAI-160)
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 hsCRP Reagent - Primary ID KAI-160
Device Regulatory Overview
The K-ASSAY hsCRP Reagent (Model/Catalog Number: KAI-160) 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-160
- Product Code / EMDN
- DCK
- Device Name
- For the quantitative determination of human C-reactive protein (CRP) in serum and plasma by immunoturbidimetric 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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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of K-ASSAY hsCRP Reagent?
The registered manufacturer of record for K-ASSAY hsCRP Reagent is KAMIYA BIOMEDICAL COMPANY, LLC.
What is the Primary UDI-DI identifier for K-ASSAY hsCRP Reagent?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is KAI-160.
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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