GUDIDData
gudid Primary ID: TP-5000 Accessory Kit

ThinPrep 5000 Processor (UDI TP-5000 Accessory Kit)

Manufactured by Hologic, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ThinPrep 5000 Processor - Primary ID TP-5000 Accessory Kit

Device Regulatory Overview

The ThinPrep 5000 Processor (Model/Catalog Number: TP-5000 Accessory Kit) is a medical device manufactured by Hologic, Inc.. This product is indexed under FDA Product Code / Category Classification MKQ 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-1095-2025 View Full Alert →

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ID: Z-0907-2025 View Full Alert →

Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD....

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ID: Z-0694-2025 View Full Alert →

Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400...

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Technical Specifications

Model Number
TP-5000 Accessory Kit
Product Code / EMDN
MKQ
Device Name
Accessory kit with components for installation of the ThinPrep 5000 processor.
Database Sync Date
2026-08-09 09:22:50

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 ThinPrep 5000 Processor?

The registered manufacturer of record for ThinPrep 5000 Processor is Hologic, Inc..

What is the Primary UDI-DI identifier for ThinPrep 5000 Processor?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is TP-5000 Accessory Kit.

What classification code is assigned to this device?

This device is registered under product classification code MKQ.

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