Tissue-Tek Genie®

FDA UDI

Class I (US FDA UDI)

by Sakura Finetek USA, Inc

Identity

Trade Name: Tissue-Tek Genie® FDA UDI
Generic Name: Dewaxing solution IVD FDA UDI
Device Name: Dewax Solution, RTU FDA UDI
Model / Reference: 8865-G001 FDA UDI
Description: Dewax Solution, RTU FDA UDI

Identifiers

Catalog Number: 8865-G001 FDA UDI
Primary DI / UDI-DI: 00615233002525 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Dewaxing solution IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.1860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Yes

FDA UDI

Category: Dewaxing solution IVD

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

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Also classified as Dewaxing solution IVD.

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TintoDewaxer, 1L — BIO SB, INC. · Class I
ONCORE Pro ISH Dewax Kit — BIOCARE MEDICAL, LLC · Class I
Aqua DePar 10X — BIOCARE MEDICAL, LLC · Class I
Dewax Solution 2, DS2 Kit — BIOCARE MEDICAL, LLC · Class I
Dewax Solution 1, DS1 — BIOCARE MEDICAL, LLC · Class I
Slide Brite — BIOCARE MEDICAL, LLC · Class I

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: Sakura Finetek USA, Inc

Sources (1)

FDA UDI 5fdd82de-0928-4b8b-81d6-3d976ce397a1 35 fields · synced May 30, 2026