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Bond™

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref PB0829

by Leica Biosystems Newcastle, Limited

Identity

Trade Name
HPV Probe (subtypes 16, 18, 31, 33, 51) 6.25 mL EUDAMED
BOND™ FDA UDI
Generic Name
Human papillomavirus (HPV) nucleic acid IVD, probe FDA UDI
Device Name
BOND Ready-to-Use ISH HPV Probe (Subtypes 16, 18, 31, 33, 51) EUDAMED
HPV Probe (Subtypes 16, 18, 31, 33, 51) is intended to be used for the qualitative identification of the Human Papillomavirus (HPV) DNA in formalin-fixed, paraffin-embedded tissue by in situ hybridization (ISH) using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system). This probe binds to the five high risk HPV subtypes, 16, 18, 31, 33 and 51. FDA UDI
Model / Reference
PB0829 EUDAMEDFDA UDI
Description
HPV Probe (Subtypes 16, 18, 31, 33, 51) is intended to be used for the qualitative identification of the Human Papillomavirus (HPV) DNA in formalin-fixed, paraffin-embedded tissue by in situ hybridization (ISH) using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system). This probe binds to the five high risk HPV subtypes, 16, 18, 31, 33 and 51. FDA UDI

Identifiers

Catalog Number
PB0829 FDA UDI
Primary DI / UDI-DI
05055331303486 EUDAMEDFDA UDI
Basic UDI-DI
B-05055331303486 EUDAMED
FDA Product Code
MVU FDA UDI
EMDN Code
W01030703 DNA IN SITU HYBRIDISATION REAGENTS EUDAMED
GMDN Term
Human papillomavirus (HPV) nucleic acid IVD, probe FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class I FDA UDI
Regulation Number
864.4020 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

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 papillomavirus (HPV) nucleic acid IVD, probe

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

Similar devices

Also classified as Human papillomavirus (HPV) nucleic acid IVD, probe.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Leica Biosystems Newcastle, Limited

Sources (2)

  • FDA UDI 07e48681-8651-4e29-8163-17df852cdeaa 36 fields · synced Jul 22, 2026
  • EUDAMED c360e40b-26fd-46c8-8ed6-5745787a1b66 61 fields · synced Jul 22, 2026