Bond™

FDA UDI

Class I (US FDA UDI)

by Leica Biosystems Newcastle, Limited

Identity

Trade Name: BOND™ FDA UDI
Generic Name: Fascin IVD, antibody FDA UDI
Device Name: Fascin (IM20) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human fascin 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: PA0420 FDA UDI
Description: Fascin (IM20) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human fascin 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: PA0420 FDA UDI
Primary DI / UDI-DI: 05055331304148 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Fascin 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

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Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

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Combination Product

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HCT/P

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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

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Category: Fascin IVD, antibody

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

Similar devices

Also classified as Fascin IVD, antibody.

Fascin (55k-2) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
Rabbit Monoclonal Anti-Human Fascin Antibody, EP116 — EPITOMICS, INC. · Class I
Rabbit Monoclonal Anti-Human Fascin Antibody, EP116 — EPITOMICS, INC. · Class I
Fascin (55k-2) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
Fascin (55k-2) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
ANTI-FASCIN — Biogenex Laboratories, Inc. · Class I
Fascin (55k-2) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
Rabbit Monoclonal Anti-Human Fascin Antibody, EP116 — EPITOMICS, INC. · 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 bdc9b005-bb02-4066-a07b-82747107a2aa 36 fields · synced May 30, 2026