K-ASSAY Cystatin C Calibrator (UDI 00816426020771)
Manufactured by KAMIYA BIOMEDICAL COMPANY, LLC
Device Regulatory Overview
The K-ASSAY Cystatin C Calibrator (Model/Catalog Number: KAI-099C) is a medical device manufactured by KAMIYA BIOMEDICAL COMPANY, LLC. This product is indexed under FDA Product Code / Category Classification W0102019008 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- KAI-099C
- Product Code / EMDN
- W0102019008
- Device Name
- Cystatin C Calibrator
- Database Sync Date
- 2026-08-09 16:29:09
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of K-ASSAY Cystatin C Calibrator?
The registered manufacturer of record for K-ASSAY Cystatin C Calibrator is KAMIYA BIOMEDICAL COMPANY, LLC.
What is the Primary UDI-DI identifier for K-ASSAY Cystatin C Calibrator?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00816426020771.
What classification code is assigned to this device?
This device is registered under product classification code W0102019008.
Similar Classification Devices (W0102019008)
Other Devices by KAMIYA BIOMEDICAL COMPANY, LLC
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint