gudid
Primary ID: 10-9517-02
ImmunoCAP Total IgE (UDI 10-9517-02)
Manufactured by Phadia AB
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ImmunoCAP Total IgE - Primary ID 10-9517-02
Technical Specifications
- Model Number
- 10-9517-02
- Product Code / EMDN
- DGC
- Device Name
- Contains one bottle of Total IgE Conjugate and four vials of each Total IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Total IgE method.
- Database Sync Date
- 2026-08-09 09:48:59
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 ImmunoCAP Total IgE?
The registered manufacturer of record for ImmunoCAP Total IgE is Phadia AB.
What is the Primary UDI-DI identifier for ImmunoCAP Total IgE?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 10-9517-02.
What classification code is assigned to this device?
This device is registered under product classification code DGC.
Similar Classification Devices (DGC)
Other Devices by Phadia AB
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