Identity
- Trade Name
- Kappa Probe 5.5 mL EUDAMEDBOND FDA UDI
- Generic Name
- Kappa/lambda light chain immunoglobulin IVD, antibody FDA UDI
- Device Name
- BOND Ready-to-Use ISH Kappa Probe EUDAMEDKappa Probe is intended for use in the qualitative identification of Kappa light chain messenger RNA (mRNA) in formalin-fixed, paraffinembedded tissue by in situ hybridization (ISH) using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system). FDA UDI
- Model / Reference
- PB0645 EUDAMEDFDA UDI
- Description
- Kappa Probe is intended for use in the qualitative identification of Kappa light chain messenger RNA (mRNA) in formalin-fixed, paraffinembedded tissue by in situ hybridization (ISH) using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system). FDA UDI
Identifiers
- Catalog Number
- PB0645 FDA UDI
- Primary DI / UDI-DI
- 05055331303554 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055331303554 EUDAMED
- FDA Product Code
- MVU FDA UDI
- EMDN Code
- W01030703 DNA IN SITU HYBRIDISATION REAGENTS EUDAMED
- GMDN Term
- Kappa/lambda light chain immunoglobulin IVD, antibody FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4020 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: Kappa/lambda light chain immunoglobulin 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
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 1ec3e0fa-677e-4403-882c-7496a76429d8 36 fields · synced Oct 7, 2026
- EUDAMED c797c145-7f83-40c3-b36b-3c607499e3c5 61 fields · synced Jun 19, 2026