K-ASSAY Hemoglobin A1c Reagent (UDI KAI-196)
Manufactured by KAMIYA BIOMEDICAL COMPANY, LLC
Device Regulatory Overview
The K-ASSAY Hemoglobin A1c Reagent (Model/Catalog Number: KAI-196) is a medical device manufactured by KAMIYA BIOMEDICAL COMPANY, LLC. This product is indexed under FDA Product Code / Category Classification LCP within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- KAI-196
- Product Code / EMDN
- LCP
- Device Name
- For the quantitative determination of human hemoglobin A1c (HbA1c) in whole blood.
- 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 Hemoglobin A1c Reagent?
The registered manufacturer of record for K-ASSAY Hemoglobin A1c Reagent is KAMIYA BIOMEDICAL COMPANY, LLC.
What is the Primary UDI-DI identifier for K-ASSAY Hemoglobin A1c Reagent?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is KAI-196.
What classification code is assigned to this device?
This device is registered under product classification code LCP.
Similar Classification Devices (LCP)
Other Devices by KAMIYA BIOMEDICAL COMPANY, LLC
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