Identity
- Trade Name
- BOND FDA UDI
- Generic Name
- Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- BOND ChromoPlex II Dual Detection is a biotin-free, polymeric horseradish peroxidase (HRP) and polymeric alkaline phosphatase (AP) antibody conjugate system for the visualization of tissue-bound mouse IgG, mouse IgM and rabbit primary antibodies. It is intended for target visualization by immunohistochemistry (IHC) or RNA chromogenic in situ hybridization (RNA CISH) in sections of formalin fixed, paraffin-embedded tissue using the automated BOND-MAX or BOND-III systems. FDA UDI
- Model / Reference
- DS9494 FDA UDI
- Description
- BOND ChromoPlex II Dual Detection is a biotin-free, polymeric horseradish peroxidase (HRP) and polymeric alkaline phosphatase (AP) antibody conjugate system for the visualization of tissue-bound mouse IgG, mouse IgM and rabbit primary antibodies. It is intended for target visualization by immunohistochemistry (IHC) or RNA chromogenic in situ hybridization (RNA CISH) in sections of formalin fixed, paraffin-embedded tissue using the automated BOND-MAX or BOND-III systems. FDA UDI
Identifiers
- Catalog Number
- DS9494 FDA UDI
- Primary DI / UDI-DI
- 05055331332820 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Bond by Leica Biosystems Newcastle, Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Leica Biosystems Newcastle, Limited
Sources (1)
- FDA UDI 819e2f01-0c4d-4bd1-b134-0b2fc5b6794f 36 fields · synced May 30, 2026