gudid
Primary ID: 06U8601
ACE Calibrator (UDI 06U8601)
Manufactured by SENTINEL CH. SPA
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ACE Calibrator - Primary ID 06U8601
Device Regulatory Overview
The ACE Calibrator (Model/Catalog Number: 06U8601) 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
- 06U8601
- Product Code / EMDN
- JIT
- Device Name
- ACE Calibrator is intended to be used with ACE Reagent for the calibration of angiotensin converting enzyme (ACE) assay on Alinity c system. Use the CALIBRATOR according to the indicated analytical procedure. For In Vitro Diagnostic use. For laboratory professional use only.
- 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 ACE Calibrator?
The registered manufacturer of record for ACE Calibrator is SENTINEL CH. SPA.
What is the Primary UDI-DI identifier for ACE Calibrator?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06U8601.
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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