Bond™

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref PA0562

by Leica Biosystems Newcastle, Limited

Identity

Trade Name: Wilms' Tumor WT49 7 mL EUDAMED
BOND™ FDA UDI
Generic Name: Wilms tumour protein IVD, antibody FDA UDI
Device Name: BOND Ready-to-Use Primary Antibody Wilms’ Tumor (WT49) EUDAMED
Wilms’ Tumor (WT49) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Wilms’ Tumor WT1 gene product. in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system). FDA UDI
Model / Reference: PA0562 EUDAMEDFDA UDI
Description: Wilms’ Tumor (WT49) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Wilms’ Tumor WT1 gene product. in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system). FDA UDI

Identifiers

Catalog Number: PA0562 FDA UDI
Primary DI / UDI-DI: 05055331303943 EUDAMEDFDA UDI
Basic UDI-DI: B-05055331303943 EUDAMED
FDA Product Code: NJT FDA UDI
EMDN Code: W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
GMDN Term: Wilms tumour protein IVD, antibody FDA UDI

Classification

Device Class: Class IVD General 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

Prescription Use

Yes

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 UDI

Category: Wilms tumour protein IVD, antibody

Bond™ by Leica Biosystems Newcastle, Limited — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Wilms tumour protein IVD, antibody.

IHC — Slmp, LLC · Class I
Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
Rabbit Monoclonal Anti-Human Wilms' Tumor Antibody, EP122 — EPITOMICS, INC. · Class I
Genemed® — Sakura Finetek USA, Inc · Class I
FLEX Mono Mo A-Hu Wilms’ Tumor 1 (WT1) Protein Cl 6F-H2 RTU (Link) — Agilent Technologies Inc. · Class I
Mouse Monoclonal Anti-Human WT1(MX012) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
Rabbit Monoclonal Anti-Human Wilms' Tumor Antibody, EP122 — EPITOMICS, INC. · Class I
WT1 [rWT1/857] — BIOCARE MEDICAL, LLC · Class I

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDD	—	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: Leica Biosystems Newcastle, Limited

Sources (2)

FDA UDI 1e19de1d-f735-4220-95ce-ba48747a6599 36 fields · synced Jul 19, 2026
EUDAMED 610e1c0b-6d8f-4cd5-975d-b4572cea2b8b 61 fields · synced Jul 19, 2026