gudid Primary ID: 1019 / A52765

Gentian Cystatin C Control Kit (2 x 1mL) (UDI 1019 / A52765)

Manufactured by Gentian AS

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Gentian Cystatin C Control Kit (2 x 1mL) (Model/Catalog Number: 1019 / A52765) is a medical device manufactured by Gentian AS. This product is indexed under FDA Product Code / Category Classification NDY within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-0099-2021 View Full Alert →

GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UD...

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Technical Specifications

Model Number: 1019 / A52765
Product Code / EMDN: NDY
Device Name
Database Sync Date: 2026-08-09 09:21:56

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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Frequently Asked Questions

Who is the primary manufacturer of Gentian Cystatin C Control Kit (2 x 1mL)?

The registered manufacturer of record for Gentian Cystatin C Control Kit (2 x 1mL) is Gentian AS.

What is the Primary UDI-DI identifier for Gentian Cystatin C Control Kit (2 x 1mL)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1019 / A52765.

What classification code is assigned to this device?

This device is registered under product classification code NDY.

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