Bond

FDA UDI

Class I (US FDA UDI)

by Leica Biosystems Newcastle, Limited

Identity

Trade Name: BOND FDA UDI
Generic Name: Cancer antigen 125 (CA125) IVD, antibody FDA UDI
Device Name: 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 BOND-MAX, BOND-III, and BOND-PRIME systems). FDA UDI
Model / Reference: PA0539-U FDA 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 BOND-MAX, BOND-III, and BOND-PRIME systems). FDA UDI

Identifiers

Catalog Number: PA0539-U FDA UDI
Primary DI / UDI-DI: 05055331335210 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Cancer antigen 125 (CA125) 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

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Implantable

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Contains Latex

FDA UDI

Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Cancer antigen 125 (CA125) IVD, antibody

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

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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 (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: Leica Biosystems Newcastle, Limited

Sources (1)

FDA UDI 3183293a-a473-4f89-b0de-e2793edf835a 36 fields · synced Jun 8, 2026