Identity
- Trade Name
- CD68 514H12 7 mL EUDAMEDBOND™ FDA UDI
- Generic Name
- CD68 cell marker IVD, antibody FDA UDI
- Device Name
- BOND Ready-to-Use Primary Antibody CD68 (514H12) EUDAMEDCD68 (514H12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD68 antigen 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
- PA0273 EUDAMEDFDA UDI
- Description
- CD68 (514H12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD68 antigen 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
- PA0273 FDA UDI
- Primary DI / UDI-DI
- 05055331304360 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055331304360 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- CD68 cell marker 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: CD68 cell marker 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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Also classified as CD68 cell marker IVD, antibody.
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- CD68 [KP1] — BIOCARE MEDICAL, LLC · Class I
- Mono Mo A-Hu CD68 Cl PG-M1 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · 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 |
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Manufacturer
- Manufacturer
- Leica Biosystems Newcastle, Limited
Sources (2)
- FDA UDI f4f889c0-d04a-4e27-9878-b09042e29109 36 fields · synced Jun 14, 2026
- EUDAMED ff8574e9-ff45-4b14-8e54-661fbc64bcee 61 fields · synced Jun 11, 2026