ThinPrep

FDA UDI

Class I (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name: ThinPrep FDA UDI
Generic Name: Biological stain IVD FDA UDI
Device Name: For cytologic staining with the ThinPrep® system. FDA UDI
Model / Reference: ThinPrep® Stain Bluing Solution, 4 L FDA UDI
Description: For cytologic staining with the ThinPrep® system. FDA UDI

Identifiers

Catalog Number: 70793-001 FDA UDI
Primary DI / UDI-DI: 15420045509702 FDA UDI
FDA Product Code: HZJ FDA UDI
GMDN Term: Biological stain IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.1850 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Biological stain IVD

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Hologic, Inc.

Sources (1)

FDA UDI a68df8ca-eb97-48a4-b06a-db8f33f8fd4d 35 fields · synced May 31, 2026