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ThinPrep

FDA UDI

Class I (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name
ThinPrep FDA UDI
Generic Name
Microscope slide maker IVD FDA UDI
Device Name
For use with a ThinPrep® processor for non-gynecological specimens. FDA UDI
Model / Reference
ThinPrep® Non-GYN Filters, 100pk FDA UDI
Description
For use with a ThinPrep® processor for non-gynecological specimens. FDA UDI

Identifiers

Catalog Number
70205-001 FDA UDI
Primary DI / UDI-DI
25420045509662 FDA UDI
FDA Product Code
KET FDA UDI
GMDN Term
Microscope slide maker IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.3010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Microscope slide maker IVD

ThinPrep by Hologic, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Microscope slide maker IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hologic, Inc.

Sources (1)

  • FDA UDI 09a040ec-0d6a-49a8-90be-295c6158b1f3 35 fields · synced Jun 6, 2026