gudid
Primary ID: 11522D
Lp(a) Cal Set (UDI 11522D)
Manufactured by SENTINEL CH. SPA
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Lp(a) Cal Set - Primary ID 11522D
Device Regulatory Overview
The Lp(a) Cal Set (Model/Catalog Number: 11522D) is a medical device manufactured by SENTINEL CH. SPA. This product is indexed under FDA Product Code / Category Classification JIT within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 11522D
- Product Code / EMDN
- JIT
- Device Name
- Lp(a) Cal Set should be used as calibration curve for the Lp(a) Ultra test. Use the Calibrator according to the indicated analytical procedure.
- Database Sync Date
- 2026-08-09 09:10:59
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 Lp(a) Cal Set?
The registered manufacturer of record for Lp(a) Cal Set is SENTINEL CH. SPA.
What is the Primary UDI-DI identifier for Lp(a) Cal Set?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 11522D.
What classification code is assigned to this device?
This device is registered under product classification code JIT.
Similar Classification Devices (JIT)
Other Devices by SENTINEL CH. SPA
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