Bond™

FDA UDI

Class I (US FDA UDI)

by Leica Biosystems Newcastle, Limited

Identity

Trade Name: BOND™ FDA UDI
Generic Name: Oct-2 IVD, antibody FDA UDI
Device Name: Oct-2 (Oct-207) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Oct-2 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: PA0532 FDA UDI
Description: Oct-2 (Oct-207) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Oct-2 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: PA0532 FDA UDI
Primary DI / UDI-DI: 05055331304025 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Oct-2 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

FDA UDI

Manufacturing Date

FDA UDI

Category: Oct-2 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-2 IVD, antibody.

Oct-2 (MRQ-2) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
Rabbit Monoclonal Anti-Human OCT-2 Antibody, EP284 — EPITOMICS, INC. · Class I
Oct-2 (MRQ-2) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
Oct-2 (MRQ-2) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
Oct-2 (MRQ-2) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
ANTI-OCT-2 — Biogenex Laboratories, Inc. · Class I
Oct-2 (MRQ-2) 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Leica Biosystems Newcastle, Limited

Sources (1)

FDA UDI 4d00556a-ad0a-4304-bd86-d59bc7e6b371 36 fields · synced Jun 8, 2026