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: Napsin A IVD, antibody FDA UDI
Device Name: anti-Napsin A Rabbit Monoclonal Antibody [EP205], 10 RTU capsules FDA UDI
Model / Reference: 8331-C010 FDA UDI
Description: anti-Napsin A Rabbit Monoclonal Antibody [EP205], 10 RTU capsules FDA UDI

Identifiers

Catalog Number: 8331-C010 FDA UDI
Primary DI / UDI-DI: 00615233001696 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Napsin A 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: Napsin A 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 Napsin A IVD, antibody.

Mouse Monoclonal Anti-Human Napsin A(MX015) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
Napsin A — BIOCARE MEDICAL, LLC · Class I
ihcDirect® Napsin A Ab-Enh 15mL — NOVODIAX, INC. · Class I
Napsin A (RM) — BIOCARE MEDICAL, LLC · Class I
Napsin A Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · Class I
Napsin A Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · Class I
Napsin A Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · Class I
Rabbit Monoclonal Anti-Human Napsin A Antibody, EP205 — EPITOMICS, 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 003bac6b-8353-4e6f-a6e4-1c78d93b88b4 35 fields · synced Jun 8, 2026