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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
Immunoglobulin A antibody (anti-IgA) IVD, reagent FDA UDI
Device Name
anti-IgA Rabbit Monoclonal Antibody [EP170], 1 RTU cartridge FDA UDI
Model / Reference
8381-M250 FDA UDI
Description
anti-IgA Rabbit Monoclonal Antibody [EP170], 1 RTU cartridge FDA UDI

Identifiers

Catalog Number
8381-M250 FDA UDI
Primary DI / UDI-DI
00615233001924 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Immunoglobulin A antibody (anti-IgA) IVD, reagent 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: Immunoglobulin A antibody (anti-IgA) IVD, reagent

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 Immunoglobulin A antibody (anti-IgA) IVD, reagent.

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 a114999f-6687-4154-9491-3d3d7e14f1a7 35 fields · synced May 31, 2026