Identity
- Trade Name
- CD56 CD564 7 mL EUDAMEDBOND™ FDA UDI
- Generic Name
- CD56 neural cell adhesion molecule-1 (NCAM-1) IVD, antibody FDA UDI
- Device Name
- BOND Ready-to-Use Primary Antibody CD56 (CD564) EUDAMEDCD56 (CD564) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD56 molecules (neural cell adhesion molecules) 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
- PA0191 EUDAMEDFDA UDI
- Description
- CD56 (CD564) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD56 molecules (neural cell adhesion molecules) 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
- PA0191 FDA UDI
- Primary DI / UDI-DI
- 05055331304506 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055331304506 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- CD56 neural cell adhesion molecule-1 (NCAM-1) 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: CD56 neural cell adhesion molecule-1 (NCAM-1) IVD, antibody
Bond™ by Leica Biosystems Newcastle, Limited — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Leica Biosystems Newcastle, Limited
Sources (2)
- FDA UDI 2a8cfa4c-d0ff-42e8-a0f1-ed164ae83220 36 fields · synced Jun 18, 2026
- EUDAMED 26888d92-e244-4be2-9bd4-cb32792a8aa0 61 fields · synced Jun 18, 2026