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: CD1a cell marker IVD, antibody FDA UDI
Device Name: anti-CD1a Rabbit Monoclonal Antibody [EP80], 10 RTU capsules FDA UDI
Model / Reference: 8246-C010 FDA UDI
Description: anti-CD1a Rabbit Monoclonal Antibody [EP80], 10 RTU capsules FDA UDI

Identifiers

Catalog Number: 8246-C010 FDA UDI
Primary DI / UDI-DI: 00615233000569 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: CD1a cell marker 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: CD1a cell marker IVD, antibody

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

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Human CD1a R-PE Conjugate — LIFE TECHNOLOGIES LIMITED · Class I
ANTI-CD1A — Biogenex Laboratories, Inc. · Class I
BOND — Leica Biosystems Newcastle, Limited · Class I
ANTI-CD1A — Biogenex Laboratories, Inc. · Class I
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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: Sakura Finetek USA, Inc

Sources (1)

FDA UDI 6265cc86-ee73-472e-86c3-99253c7ff5ec 35 fields · synced Jun 1, 2026