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: ETS-related gene (ERG) protein IVD, antibody FDA UDI
Device Name: anti-ERG Rabbit Monoclonal Antibody [EP111], 10 RTU capsules FDA UDI
Model / Reference: 8323-C010 FDA UDI
Description: anti-ERG Rabbit Monoclonal Antibody [EP111], 10 RTU capsules FDA UDI

Identifiers

Catalog Number: 8323-C010 FDA UDI
Primary DI / UDI-DI: 00615233007353 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: ETS-related gene (ERG) protein IVD, antibody 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

Yes

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: ETS-related gene (ERG) protein IVD, antibody

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

Similar devices

Also classified as ETS-related gene (ERG) protein IVD, antibody.

ERG — BIOCARE MEDICAL, LLC · Class I
IHC — Slmp, LLC · Class I
ERG (EP111) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
FLEX Mono Rb A-Hu ERG Cl EP111 RTU (Dako Omnis) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
ANTI-ERG — Biogenex Laboratories, Inc. · Class I
ERG (EP111) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
Rabbit Monoclonal Anti-Human ERG Antibody, EP111 — EPITOMICS, INC. · Class I
ANTI-ERG — Biogenex Laboratories, Inc. · 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 f4ba37d2-62c2-4f5c-8b7a-15aaaa505de2 35 fields · synced Jun 1, 2026