GUDIDData
gudid Primary ID: ThinPrep Pap Test Filters, 100pk tray

ThinPrep Pap Test (UDI ThinPrep Pap Test Filters, 100pk tray)

Manufactured by Hologic, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ThinPrep Pap Test - Primary ID ThinPrep Pap Test Filters, 100pk tray

Device Regulatory Overview

The ThinPrep Pap Test (Model/Catalog Number: ThinPrep Pap Test Filters, 100pk tray) 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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🔒 Compromised Lot & Serial Numbers Locked
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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....

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0694-2025 View Full Alert →

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

🔒 Compromised Lot & Serial Numbers Locked
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Technical Specifications

Model Number
ThinPrep Pap Test Filters, 100pk tray
Product Code / EMDN
MKQ
Device Name
For use with a ThinPrep processor for gynecological specimens.
Database Sync Date
2026-08-09 10:01:33

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 Pap Test?

The registered manufacturer of record for ThinPrep Pap Test is Hologic, Inc..

What is the Primary UDI-DI identifier for ThinPrep Pap Test?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is ThinPrep Pap Test Filters, 100pk tray.

What classification code is assigned to this device?

This device is registered under product classification code MKQ.

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