← Back to catalogue

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
CD34 cell marker IVD, kit, enzyme immunohistochemistry FDA UDI
Device Name
anti-CD34 Mouse Monoclonal Antibody [QBEnd/10], 1 RTU cartridge FDA UDI
Model / Reference
8268-M250 FDA UDI
Description
anti-CD34 Mouse Monoclonal Antibody [QBEnd/10], 1 RTU cartridge FDA UDI

Identifiers

Catalog Number
8268-M250 FDA UDI
Primary DI / UDI-DI
00615233000842 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
CD34 cell marker IVD, kit, enzyme immunohistochemistry 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

No

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: CD34 cell marker IVD, kit, enzyme immunohistochemistry

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 CD34 cell marker IVD, kit, enzyme immunohistochemistry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sakura Finetek USA, Inc

Sources (1)

  • FDA UDI 7ed20d06-8010-4035-9576-b5395c1ea75f 35 fields · synced Jun 6, 2026