Identity
- Trade Name
- BOND™ FDA UDI
- Generic Name
- Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody FDA UDI
- Device Name
- c-erbB-2 Oncoprotein (CB11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of c-erbB-2 oncoprotein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system). FDA UDI
- Model / Reference
- PA0983-U FDA UDI
- Description
- c-erbB-2 Oncoprotein (CB11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of c-erbB-2 oncoprotein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system). FDA UDI
Identifiers
- Catalog Number
- PA0983-U FDA UDI
- Primary DI / UDI-DI
- 05055331336712 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody 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: Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody
Bond™ by Leica Biosystems Newcastle, Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody.
- Tinto HER2 neu Phospho RMab — BIO SB, INC. · Class I
- c-erbB-2/HER2 — BIOCARE MEDICAL, LLC · Class I
- ANTI-C-ERBB-2 (HER-2/NEU) — Biogenex Laboratories, Inc. · Class I
- ANTI-HER2/ERBB2 — Biogenex Laboratories, Inc. · Class I
- Rabbit Monoclonal Anti-Human HER2 / ErbB2 Antibody, EP3 — EPITOMICS, INC. · Class I
- HER2 neu Phospho RMab — BIO SB, INC. · Class I
- HER2 neu Phospho RMab — BIO SB, INC. · Class I
- Poly Rb A-Hu c-erbB-2 Oncoprotein — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Leica Biosystems Newcastle, Limited
Sources (1)
- FDA UDI 82c99168-dd3b-4b9f-b464-61958613e0f5 36 fields · synced May 30, 2026