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BOND ORACLE HER2 IHC System

FDA UDI

Class III (US FDA UDI)

by Leica Biosystems Newcastle, Limited

Identity

Trade Name
BOND ORACLE HER2 IHC System FDA UDI
Generic Name
Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, enzyme immunohistochemistry FDA UDI
Device Name
Bond Oracle HER2 IHC System is a semi quantitative immunohistochemical assay to determine HER2 oncoprotein status in breast cancer in breast tissue processed for histological evaluation. FDA UDI
Model / Reference
TA9145 FDA UDI
Description
Bond Oracle HER2 IHC System is a semi quantitative immunohistochemical assay to determine HER2 oncoprotein status in breast cancer in breast tissue processed for histological evaluation. FDA UDI

Identifiers

Catalog Number
TA9145 FDA UDI
Primary DI / UDI-DI
05055331301291 FDA UDI
FDA Product Code
MVC FDA UDI
GMDN Term
Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, enzyme immunohistochemistry FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, enzyme immunohistochemistry

BOND ORACLE HER2 IHC System by Leica Biosystems Newcastle, Limited — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, enzyme immunohistochemistry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Leica Biosystems Newcastle, Limited

Sources (1)

  • FDA UDI a7475889-95a1-4916-a866-cf51a7ff5642 36 fields · synced May 31, 2026