Identity
- Trade Name
- CD138 MI15 7 mL EUDAMEDBOND™ FDA UDI
- Generic Name
- CD138 cell marker IVD, antibody FDA UDI
- Device Name
- BOND Ready-to-Use Primary Antibody CD138 (MI15) EUDAMEDCD138 (MI15) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD138 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BONDMAX system and Leica BOND-III system). FDA UDI
- Model / Reference
- PA0088 EUDAMEDFDA UDI
- Description
- CD138 (MI15) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD138 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BONDMAX system and Leica BOND-III system). FDA UDI
Identifiers
- Catalog Number
- PA0088 FDA UDI
- Primary DI / UDI-DI
- 05055331304643 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055331304643 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- CD138 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: CD138 cell marker 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 CD138 cell marker IVD, antibody.
- Rabbit Monoclonal Anti-Human CD138 Antibody, EP201 — EPITOMICS, INC. · Class I
- Horizon — BECTON DICKINSON AND COMPANY · Class I
- FLEX Mono Mo A-Hu CD138 Cl MI15 RTU — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- CD138-PE — CYTOGNOS SL · Class I
- CD138 (EP201) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- Mono Mo A-Hu CD138/APC Cl MI15 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- CD138 — BIOCARE MEDICAL, LLC · Class I
- CD138 (RBT-CD138) — BIO SB, 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 |
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Manufacturer
- Manufacturer
- Leica Biosystems Newcastle, Limited
Sources (2)
- FDA UDI 175df172-313a-44fe-b625-8d05846f40ef 36 fields · synced Jun 19, 2026
- EUDAMED 54de6b19-0fd0-4c60-a5ca-62d65f9245b7 61 fields · synced Jun 19, 2026