Bond™

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref PA0539

by Leica Biosystems Newcastle, Limited

Identity

Trade Name: CA125 Ov185:1 7mL EUDAMED
BOND™ FDA UDI
Generic Name: Cancer antigen 125 (CA125) IVD, antibody FDA UDI
Device Name: BOND Ready-To-Use Primary Antibody CA125 (Ovarian Cancer Antigen)(Ov185:1) EUDAMED
CA125 (Ovarian Cancer Antigen)(Ov185:1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of repetitive protein determinant expressed in the protein core of the CA125 human ovarian cancer antigen 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: PA0539 EUDAMEDFDA UDI
Description: CA125 (Ovarian Cancer Antigen)(Ov185:1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of repetitive protein determinant expressed in the protein core of the CA125 human ovarian cancer antigen 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: PA0539 FDA UDI
Primary DI / UDI-DI: 05055331304001 EUDAMEDFDA UDI
Basic UDI-DI: B-05055331304001 EUDAMED
FDA Product Code: NJT FDA UDI
EMDN Code: W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
GMDN Term: Cancer antigen 125 (CA125) 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: Cancer antigen 125 (CA125) 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 Cancer antigen 125 (CA125) IVD, antibody.

ANTI-CA125 — Biogenex Laboratories, Inc. · Class I
Rabbit Monoclonal Anti-Human CA 125 Antibody, EP48 — EPITOMICS, INC. · Class I
Tinto CA-125 RMab — BIO SB, INC. · Class I
FLEX Mono Mo A-Hu CA 125 Cl M11 RTU (Link) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
CA-125 RMab — BIO SB, INC. · Class I
FLEX Mono Mo A-Hu CA 125 Cl M11 RTU — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
CA-125 (OC125) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
CA-125 (OC125) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · 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

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Manufacturer

Manufacturer: Leica Biosystems Newcastle, Limited

Sources (2)

FDA UDI cdce6e44-6e30-4d20-b05f-d713fb53ce33 36 fields · synced Jun 19, 2026
EUDAMED 811f7f60-77cc-4188-99c5-b66a524f335d 61 fields · synced Jun 19, 2026