gudid Primary ID: 210543

Neg Control (UDI 210543)

Manufactured by DIAGAST

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Neg Control (Model/Catalog Number: 210543) is a medical device manufactured by DIAGAST. This product is indexed under FDA Product Code / Category Classification KSF within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 210543
Product Code / EMDN: KSF
Device Name: Negative control reagent for Anti-D Monoclonal Blood Grouping Reagents (210524-210525-210526) for manual tube technique
Database Sync Date: 2026-08-09 10:01:36

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 Neg Control?

The registered manufacturer of record for Neg Control is DIAGAST.

What is the Primary UDI-DI identifier for Neg Control?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 210543.

What classification code is assigned to this device?

This device is registered under product classification code KSF.

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