gudid
Primary ID: KAI-091C
K-ASSAY D-Dimer Calibrator (UDI KAI-091C)
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 D-Dimer Calibrator - Primary ID KAI-091C
Device Regulatory Overview
The K-ASSAY D-Dimer Calibrator (Model/Catalog Number: KAI-091C) is a medical device manufactured by KAMIYA BIOMEDICAL COMPANY, LLC. This product is indexed under FDA Product Code / Category Classification GHH within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- KAI-091C
- Product Code / EMDN
- GHH
- Device Name
- For the calibration of the K-ASSAY D-Dimer 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 D-Dimer Calibrator?
The registered manufacturer of record for K-ASSAY D-Dimer Calibrator is KAMIYA BIOMEDICAL COMPANY, LLC.
What is the Primary UDI-DI identifier for K-ASSAY D-Dimer Calibrator?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is KAI-091C.
What classification code is assigned to this device?
This device is registered under product classification code GHH.
Similar Classification Devices (GHH)
Other Devices by KAMIYA BIOMEDICAL COMPANY, LLC
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