BOND-PRIME Polymer DAB Detection System
EUDAMEDFDA UDIClass A (EU MDR)
Identity
- Trade Name
- BOND-PRIME Polymer DAB Detection System EUDAMEDBOND-PRIME FDA UDI
- Generic Name
- Immunohistochemistry antibody detection IVD, reagent FDA UDI
- Device Name
- BOND-PRIME Polymer DAB Detection System EUDAMEDBOND-PRIME Polymer DAB Detection System 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
- DS9284 EUDAMEDFDA UDI
- Description
- BOND-PRIME Polymer DAB Detection System 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
- DS9284 FDA UDI
- Primary DI / UDI-DI
- 05055331331014 EUDAMEDFDA UDI
- Basic UDI-DI
- 50553313PRIDAB00005T6 EUDAMED
- Direct Marketing DI
- 05055331331014 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030711 IMMUNOHISTOLOGY KITS EUDAMED
- GMDN Term
- Immunohistochemistry antibody detection IVD, reagent 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-PRIME Polymer DAB Detection System by Leica Biosystems Newcastle Ltd — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 50553313PRIDAB00005T6 | 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
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED eeff413f-e35d-4c13-8394-97ce035e1cc3 61 fields · synced Jun 18, 2026
- FDA UDI 7dc17659-6244-494a-9d42-e2b3520574ef 36 fields · synced May 30, 2026