K-ASSAY Coagulation Control (UDI K104C-10M)
Manufactured by KAMIYA BIOMEDICAL COMPANY, LLC
Device Regulatory Overview
The K-ASSAY Coagulation Control (Model/Catalog Number: K104C-10M) is a medical device manufactured by KAMIYA BIOMEDICAL COMPANY, LLC. This product is indexed under FDA Product Code / Category Classification DBT within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- K104C-10M
- Product Code / EMDN
- DBT
- Device Name
- For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
- 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 Coagulation Control?
The registered manufacturer of record for K-ASSAY Coagulation Control is KAMIYA BIOMEDICAL COMPANY, LLC.
What is the Primary UDI-DI identifier for K-ASSAY Coagulation Control?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is K104C-10M.
What classification code is assigned to this device?
This device is registered under product classification code DBT.
Similar Classification Devices (DBT)
Other Devices by KAMIYA BIOMEDICAL COMPANY, LLC
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