Glycosylated Hemoglobin (HbA1c) (Ion Exchange) (UDI 62230182715366)
Manufactured by Kalians Corporation
Device Regulatory Overview
The Glycosylated Hemoglobin (HbA1c) (Ion Exchange) (Model/Catalog Number: D-659 001) is a medical device manufactured by Kalians Corporation. This product is indexed under FDA Product Code / Category Classification W01010214 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- D-659 001
- Product Code / EMDN
- W01010214
- Device Name
- Glycosylated Hemoglobin (HbA1c) (Ion Exchange)
- Database Sync Date
- 2026-08-09 16:30:07
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 Glycosylated Hemoglobin (HbA1c) (Ion Exchange)?
The registered manufacturer of record for Glycosylated Hemoglobin (HbA1c) (Ion Exchange) is Kalians Corporation.
What is the Primary UDI-DI identifier for Glycosylated Hemoglobin (HbA1c) (Ion Exchange)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 62230182715366.
What classification code is assigned to this device?
This device is registered under product classification code W01010214.
Similar Classification Devices (W01010214)
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