Identity
- Trade Name
- CD30 JCM182 7 mL EUDAMEDBOND™ FDA UDI
- Generic Name
- Tumour necrosis factor receptor superfamily IVD, antibody FDA UDI
- Device Name
- BOND Ready-to-Use Primary Antibody CD30 (JCM182) EUDAMEDCD30 (JCM182) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of CD30 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
- PA0790 EUDAMEDFDA UDI
- Description
- CD30 (JCM182) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of CD30 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
- PA0790 FDA UDI
- Primary DI / UDI-DI
- 05055331303820 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055331303820 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Tumour necrosis factor receptor superfamily 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
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Tumour necrosis factor receptor superfamily 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 Tumour necrosis factor receptor superfamily IVD, antibody.
- Nerve Growth Factor Receptor (NGFR) (MRQ-21) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- CD30 (Ber-H2) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Mono Mo A-Hu CD30/FITC Cl Ber-H2 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- OX40/CD134 — BIOCARE MEDICAL, LLC · Class I
- CD137 — BIOCARE MEDICAL, LLC · Class I
- IHC — Slmp, LLC · Class I
- p120 + E-cadherin — BIOCARE MEDICAL, LLC · Class I
- CD30 (Ber-H2) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
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 0379c84e-a973-410f-ac35-9bf627abd207 36 fields · synced Jun 18, 2026
- EUDAMED 44d874d8-1485-4518-bd5a-c44ac9f4cf79 61 fields · synced Jun 18, 2026