GUDIDData
gudid Primary ID: 0009802100

HemosIL AcuStar D-Dimer Controls (UDI 0009802100)

Manufactured by INSTRUMENTATION LABORATORY COMPANY

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HemosIL AcuStar D-Dimer Controls - Primary ID 0009802100

Device Regulatory Overview

The HemosIL AcuStar D-Dimer Controls (Model/Catalog Number: 0009802100) is a medical device manufactured by INSTRUMENTATION LABORATORY COMPANY. This product is indexed under FDA Product Code / Category Classification GGN within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
0009802100
Product Code / EMDN
GGN
Device Name
HemosIL AcuStar D-Dimer Controls
Database Sync Date
2026-08-09 09:10:49

Full Regulatory Attributes

🔒 Token Gated
{
    "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 HemosIL AcuStar D-Dimer Controls?

The registered manufacturer of record for HemosIL AcuStar D-Dimer Controls is INSTRUMENTATION LABORATORY COMPANY.

What is the Primary UDI-DI identifier for HemosIL AcuStar D-Dimer Controls?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 0009802100.

What classification code is assigned to this device?

This device is registered under product classification code GGN.

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