gudid Primary ID: HC-121

Hemoglobin Variant Control Kit (UDI HC-121)

Manufactured by ANALYTICAL CONTROL SYSTEMS INC

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Hemoglobin Variant Control Kit (Model/Catalog Number: HC-121) is a medical device manufactured by ANALYTICAL CONTROL SYSTEMS INC. This product is indexed under FDA Product Code / Category Classification within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: HC-121
Product Code / EMDN: N/A
Device Name
Database Sync Date: 2026-08-09 09:32:57

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 Hemoglobin Variant Control Kit?

The registered manufacturer of record for Hemoglobin Variant Control Kit is ANALYTICAL CONTROL SYSTEMS INC.

What is the Primary UDI-DI identifier for Hemoglobin Variant Control Kit?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is HC-121.

What classification code is assigned to this device?

This device is registered under product classification code .

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