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Sign in to claim this brandAsahi Kasei Pharma Corporation
US
Last updated May 30, 2026
What Asahi Kasei Pharma Corporation makes
Asahi Kasei Pharma Corporation manufactures in vitro diagnostic reagents, calibrators, and controls for the measurement of glycated albumin. Their product portfolio includes the Lucica Glycated Albumin-L system, which consists of specific reagents for glycated albumin and albumin testing.
These medical devices are categorized as Class I and Class II products. The company is based in the United States, and its devices are listed in the FDA 510(k) and FDA UDI databases.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Asahi Kasei Pharma Corporation manufacture?
Asahi Kasei Pharma Corporation specializes in the production of in vitro diagnostic reagents, calibrators, and controls. Their primary product portfolio is centered on the Lucica Glycated Albumin-L system, which is designed for the measurement of glycated albumin and albumin testing. This focus allows the company to provide a comprehensive set of tools for clinical laboratory diagnostics.
Where is Asahi Kasei Pharma Corporation based?
Asahi Kasei Pharma Corporation is based in the United States. This location serves as the operational base for the company's activities related to the manufacturing and distribution of their in vitro diagnostic products.
How are the devices from Asahi Kasei Pharma Corporation classified and regulated?
The medical devices produced by Asahi Kasei Pharma Corporation are categorized as Class I and Class II products. These devices are subject to regulatory oversight and are officially listed in the FDA 510(k) and FDA UDI databases, which track medical device information and premarket notifications to ensure transparency and regulatory compliance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- ekfdiagnostics.com
- —
- —
- [email protected]
- Phone
- +18005315535
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 700853096
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Lucica® Glycated Albumin-L GA R-1 | L212GA | FDA UDI | Class II | Active |
| Lucica® Glycated Albumin-L ALB R-1 | L232GA | FDA UDI | Class II | Active |
| Lucica® Glycated Albumin-L ALB R-2 | L242GA | FDA UDI | Class II | Active |
| Lucica® Glycated Albumin-L GA R-2 | L222GA | FDA UDI | Class II | Active |
| Calibrator for Lucica® Glycated Albumin-L | G252GA | FDA UDI | Class II | Active |
| Control for Lucica® Glycated Albumin-L | G282GA | FDA UDI | Class I | Active |
| Lucica Glycated Albumin-L | K170147 | FDA 510(k) | Class II | Active |
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