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: SOXC protein IVD, antibody FDA UDI
Device Name: anti-SOX11 Mouse Monoclonal Antibody [GM032], 1 RTU cartridge FDA UDI
Model / Reference: 8521-M250 FDA UDI
Description: anti-SOX11 Mouse Monoclonal Antibody [GM032], 1 RTU cartridge FDA UDI

Identifiers

Catalog Number: 8521-M250 FDA UDI
Primary DI / UDI-DI: 00615233008664 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: SOXC protein 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

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: SOXC protein 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 SOXC protein IVD, antibody.

SOX-11 (MRQ-58) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
Tinto SOX-11 (BSB-167) — BIO SB, INC. · Class I
Tinto SOX-11 (BSB-167) — BIO SB, INC. · Class I
Tinto SOX-11 (BSB-184) — BIO SB, INC. · Class I
SOX11 (M) — BIOCARE MEDICAL, LLC · Class I
SOX-11 (MRQ-58) Mouse Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
SOX-11 (BSB-167) — BIO SB, INC. · Class I
SOX11 (M) — BIOCARE MEDICAL, LLC · 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 5535ef31-effa-40b8-ae1f-74a434eedcf3 35 fields · synced May 30, 2026