Beta-Catenin (14) Mouse Monoclonal Antibody

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 760-4242Ref 224M-14Model 224M-1X seriesRef 224M-15

by Cell Marque Corporation

Identity

Trade Name: Beta-Catenin (14) Mouse Monoclonal Antibody EUDAMEDFDA UDI
Generic Name: Beta-catenin IVD, antibody FDA UDI
Device Name: Beta-Catenin (14) Mouse Monoclonal Antibody EUDAMED
Model / Reference: 224M-14 EUDAMEDFDA UDI
760-4242 EUDAMEDFDA UDI
224M-15 EUDAMEDFDA UDI
224M-1X series EUDAMED
224M-18 FDA UDI

Identifiers

Primary DI / UDI-DI: 00841683128090 EUDAMEDFDA UDI
00841683100454 EUDAMEDFDA UDI
00841683128106 EUDAMEDFDA UDI
00841683128137 FDA UDI
Basic UDI-DI: 008416831760-4242ZV EUDAMED
008416831224M-1BM EUDAMED
FDA Product Code: NJT FDA UDI
EMDN Code: W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
GMDN Term: Beta-catenin IVD, antibody FDA UDI

Classification

Device Class: Class C EUDAMED
Class I FDA UDI
Regulation Number: 864.1860 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

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

FDA UDIFDA UDI

Category: Beta-catenin IVD, antibody

Beta-Catenin (14) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Beta-catenin IVD, antibody.

Rabbit Monoclonal Anti-Human Beta-Catenin(MXR022) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
Tinto Beta-Catenin, RMab — BIO SB, INC. · Class I
Tinto Beta-Catenin, RMab — BIO SB, INC. · Class I
Beta-Catenin — BIOCARE MEDICAL, LLC · Class I
Novocastra — Leica Biosystems Newcastle, Limited · Class I
FLEX Mono Mo A-Hu Beta-Catenin Cl ß-Catenin-1 RTU (Dako Omnis) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
Rabbit Monoclonal Anti-Human Beta-Catenin(MXR022) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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

Manufacturer

Manufacturer: Cell Marque Corporation

Sources (7)

FDA UDI cc480781-7d1b-4eb4-8e86-bbf66a43fbfe 33 fields · synced Jul 10, 2026
FDA UDI ffdeaefd-506d-41f6-a181-4bd09403d9bc 33 fields · synced May 30, 2026
FDA UDI 8a94d947-3201-4a50-aa4a-e084ffd656f7 33 fields · synced May 30, 2026
FDA UDI 3240c33d-4982-47b0-b746-72887f13b884 33 fields · synced May 30, 2026
EUDAMED 892c72d8-9e48-4751-a750-a27d77ef94f9 61 fields · synced Jul 9, 2026
EUDAMED 061cde0d-7854-4fb6-9498-86e7b4d9705c 61 fields · synced Jul 9, 2026
EUDAMED 075961ee-dbf8-4b5e-ac6f-5537d0ebe616 61 fields · synced Jul 10, 2026