Identity
- Trade Name
- Novocastra™ FDA UDI
- Generic Name
- Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody FDA UDI
- Device Name
- NCL-L-CB11 is intended for the qualitative identification by light microscopy of c-erbB-2 Oncoprotein molecules in paraffin sections. FDA UDI
- Model / Reference
- CB11-L-CE FDA UDI
- Description
- NCL-L-CB11 is intended for the qualitative identification by light microscopy of c-erbB-2 Oncoprotein molecules in paraffin sections. FDA UDI
Identifiers
- Catalog Number
- NCL-L-CB11 FDA UDI
- Primary DI / UDI-DI
- 05055331315304 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
Novocastra™ by Leica Biosystems Newcastle, Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody.
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- 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
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- 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 |
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Manufacturer
- Manufacturer
- Leica Biosystems Newcastle, Limited
Sources (1)
- FDA UDI c0a0bf3e-b8ec-48e2-b814-7c4e476139ce 36 fields · synced May 30, 2026