Bond™

FDA UDI

Class I (US FDA UDI)

by Leica Biosystems Newcastle, Limited

Identity

Trade Name: BOND™ FDA UDI
Generic Name: Oct-3/4 IVD, antibody FDA UDI
Device Name: Oct-3/4 (N1NK) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Oct-3/4 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system). FDA UDI
Model / Reference: PA0934 FDA UDI
Description: Oct-3/4 (N1NK) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Oct-3/4 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system). FDA UDI

Identifiers

Catalog Number: PA0934 FDA UDI
Primary DI / UDI-DI: 05055331303752 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Oct-3/4 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

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

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Manufacturing Date

FDA UDI

Category: Oct-3/4 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 Oct-3/4 IVD, antibody.

OCT 3/4 [N1NK] — BIOCARE MEDICAL, LLC · Class I
OCT 3/4 [N1NK] — BIOCARE MEDICAL, LLC · Class I
Mouse Monoclonal Anti-Human OCT3/4(MX084) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
OCT 3/4 [N1NK] — BIOCARE MEDICAL, LLC · Class I
Mouse Monoclonal Anti-Human OCT3/4(MX084) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
OCT 3/4 [N1NK] — BIOCARE MEDICAL, LLC · Class I
OCT 3/4 [N1NK] — BIOCARE MEDICAL, LLC · Class I
OCT 3/4 [N1NK] — BIOCARE MEDICAL, LLC · 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 c1114084-f282-4be5-97b5-2d1b4f24f5bb 36 fields · synced Jun 8, 2026