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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
Human herpesvirus 8 (HHV8) antigen IVD, antibody FDA UDI
Device Name
anti-HHV-8 Mouse Monoclonal Antibody [13B10], 10 RTU capsules FDA UDI
Model / Reference
8378-C010 FDA UDI
Description
anti-HHV-8 Mouse Monoclonal Antibody [13B10], 10 RTU capsules FDA UDI

Identifiers

Catalog Number
8378-C010 FDA UDI
Primary DI / UDI-DI
00615233001900 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Human herpesvirus 8 (HHV8) antigen 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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: Human herpesvirus 8 (HHV8) antigen 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 Human herpesvirus 8 (HHV8) antigen IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sakura Finetek USA, Inc

Sources (1)

  • FDA UDI 8c7efb76-1ea3-42de-b328-935754053dfd 35 fields · synced Jun 8, 2026