Bond

FDA UDI

Class I (US FDA UDI)

by Leica Biosystems Newcastle, Limited

Identity

Trade Name: BOND FDA UDI
Generic Name: D2-40 antigen IVD, antibody FDA UDI
Device Name: This reagent is for in vitro diagnostic use. Podoplanin (D2-40) is intended to be used for the qualitative identification by light microscopy of human Podoplanin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX, BOND-III or BOND-PRIME systems. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist. FDA UDI
Model / Reference: PA0240-U FDA UDI
Description: This reagent is for in vitro diagnostic use. Podoplanin (D2-40) is intended to be used for the qualitative identification by light microscopy of human Podoplanin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX, BOND-III or BOND-PRIME systems. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist. FDA UDI

Identifiers

Catalog Number: PA0240-U FDA UDI
Primary DI / UDI-DI: 05055331336903 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: D2-40 antigen 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: D2-40 antigen 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 D2-40 antigen IVD, antibody.

D2-40 — BIOCARE MEDICAL, LLC · Class I
Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
D2-40 (Lymphatic Marker) — BIOCARE MEDICAL, LLC · Class I
D2-40 — BIOCARE MEDICAL, LLC · Class I
D2-40 (Lymphatic Marker) — BIOCARE MEDICAL, LLC · Class I
FLEX Mono Mo A-Hu Podoplanin Cl D2-40 RTU (Link) — Agilent Technologies Inc. · Class I
D2-40 — BIOCARE MEDICAL, LLC · Class I
Tissue-Tek Genie® — Sakura Finetek USA, 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

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

Manufacturer

Manufacturer: Leica Biosystems Newcastle, Limited

Sources (1)

FDA UDI f7bc5c57-3c7d-4096-bb4c-c84a325d81e4 36 fields · synced May 30, 2026