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gudid Primary ID: A19611

Thermo Scientific Infinity for Beckman Coulter SYNCHRON Systems (UDI A19611)

Manufactured by Fisher Diagnostics

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Thermo Scientific Infinity for Beckman Coulter SYNCHRON Systems - Primary ID A19611

Device Regulatory Overview

The Thermo Scientific Infinity for Beckman Coulter SYNCHRON Systems (Model/Catalog Number: A19611) is a medical device manufactured by Fisher Diagnostics. This product is indexed under FDA Product Code / Category Classification NDW within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-1503-2025 View Full Alert →

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🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-1502-2025 View Full Alert →

Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays....

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
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ID: Z-2762-2017 View Full Alert →

Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fish...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
A19611
Product Code / EMDN
NDW
Device Name
Database Sync Date
2026-08-09 09:21:10

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 Thermo Scientific Infinity for Beckman Coulter SYNCHRON Systems?

The registered manufacturer of record for Thermo Scientific Infinity for Beckman Coulter SYNCHRON Systems is Fisher Diagnostics.

What is the Primary UDI-DI identifier for Thermo Scientific Infinity for Beckman Coulter SYNCHRON Systems?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is A19611.

What classification code is assigned to this device?

This device is registered under product classification code NDW.

Similar Classification Devices (NDW)

Other Devices by Fisher Diagnostics

Programmatic Export

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