Identity
- Trade Name
- BOND Polymer Refine Detection EUDAMEDBOND FDA UDI
- Generic Name
- Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- BOND Polymer Refine Detection EUDAMEDBOND Polymer Refine Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker antibody conjugate system intended for the visualization of tissue-bound mouse IgG, mouse IgM and rabbit primary antibodies. FDA UDI
- Model / Reference
- DS9800 EUDAMEDFDA UDI
- Description
- BOND Polymer Refine Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker antibody conjugate system intended for the visualization of tissue-bound mouse IgG, mouse IgM and rabbit primary antibodies. FDA UDI
Identifiers
- Catalog Number
- DS9800 FDA UDI
- Primary DI / UDI-DI
- 05055331310460 EUDAMEDFDA UDI
- Basic UDI-DI
- 50553313POLREF000056R EUDAMED
- Direct Marketing DI
- 05055331310460 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030711 IMMUNOHISTOLOGY KITS EUDAMED
- GMDN Term
- Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry FDA UDI
Classification
- Device Class
- Class A 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
New Device
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: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
BOND Polymer Refine Detection by Leica Biosystems Newcastle Ltd — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 50553313POLREF000056R | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Leica Biosystems Newcastle Ltd
- EUDAMED SRN
- GB-MF-000020595
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED c3779d74-80ff-4f96-b248-917086dd85a6 61 fields · synced Oct 6, 2026
- FDA UDI 429aa18c-7180-4fdf-ba36-70da0fce0514 36 fields · synced May 30, 2026