Identity
- Trade Name
- Programmed Death Ligand 1 73-10 7 mL EUDAMEDBOND™ FDA UDI
- Generic Name
- Programmed death-ligand 1 (PD-L1) IVD, antibody FDA UDI
- Device Name
- BOND Ready-to-Use Primary Antibody Programmed Death Ligand 1 (73-10) EUDAMEDProgrammed Death Ligand 1 (73-10) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of endogenous PD-L1 protein 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
- PA0832 EUDAMEDFDA UDI
- Description
- Programmed Death Ligand 1 (73-10) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of endogenous PD-L1 protein 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
- PA0832 FDA UDI
- Primary DI / UDI-DI
- 05055331328908 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055331328908 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Programmed death-ligand 1 (PD-L1) IVD, antibody FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 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
No
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: Programmed death-ligand 1 (PD-L1) IVD, antibody
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 Programmed death-ligand 1 (PD-L1) IVD, antibody.
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- Anti PD-L1 Antibody — INCELLDX, INC · Class I
- MedSource CCN Cup & Tube Only — MEDSOURCE INTERNATIONAL LLC · Class II
- Rabbit Monoclonal Anti-Human PD-L1 Antibody, 28-8 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human PD-L1 Antibody, 28-8 — EPITOMICS, INC. · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- MedSource Continuous Flow Nebulizer w/Mask — MEDSOURCE INTERNATIONAL LLC · Class II
- ANTI-PDL-1 — Biogenex Laboratories, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| 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 (2)
- FDA UDI b5502c66-e001-49ba-87b2-48ce751ecc6b 36 fields · synced Jun 18, 2026
- EUDAMED 37d19b64-d252-46ec-8aa4-82e04207ea82 61 fields · synced Jun 18, 2026