← Back to catalogue

Tissue-Tek Xpress®

FDA UDI

Class I (US FDA UDI)

by Sakura Finetek USA, Inc

Identity

Trade Name
Tissue-Tek Xpress® FDA UDI
Generic Name
Histology tissue processing reagent kit IVD FDA UDI
Device Name
Processing Reagent Set, Formula 1 FDA UDI
Model / Reference
7110 FDA UDI
Description
Processing Reagent Set, Formula 1 FDA UDI

Identifiers

Catalog Number
7110 FDA UDI
Primary DI / UDI-DI
00615233081483 FDA UDI
FDA Product Code
PPM FDA UDI
GMDN Term
Histology tissue processing reagent kit IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Category: Histology tissue processing reagent kit IVD

Tissue-Tek Xpress® by Sakura Finetek USA, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Histology tissue processing reagent kit IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sakura Finetek USA, Inc

Sources (1)

  • FDA UDI 6f22caec-4d1c-4185-bb90-4a7f0ecd9f0b 35 fields · synced May 30, 2026