ThinPrep (UDI APTIMA TUBE PRINTER, THINPREP GENESIS)
Manufactured by Hologic, Inc.
Device Regulatory Overview
The ThinPrep (Model/Catalog Number: APTIMA TUBE PRINTER, THINPREP GENESIS) 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.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- APTIMA TUBE PRINTER, THINPREP GENESIS
- Product Code / EMDN
- MKQ
- Device Name
- Accessory to the Genesis processor for automated label printing on a specimen tube.
- Database Sync Date
- 2026-08-09 09:22:50
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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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of ThinPrep?
The registered manufacturer of record for ThinPrep is Hologic, Inc..
What is the Primary UDI-DI identifier for ThinPrep?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is APTIMA TUBE PRINTER, THINPREP GENESIS.
What classification code is assigned to this device?
This device is registered under product classification code MKQ.
Similar Classification Devices (MKQ)
Other Devices by Hologic, Inc.
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