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PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody FDA UDI
- Generic Name
- Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody FDA UDI
- Model / Reference
- 50 tests FDA UDI
Identifiers
- Catalog Number
- 05278368001 FDA UDI
- Primary DI / UDI-DI
- 04015630972197 FDA UDI
- FDA Product Code
- MVC FDA UDI
- GMDN Term
- Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody FDA UDI
Classification
- Device Class
- Class III 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
No
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
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody by Ventana Medical Systems — Class III — FDA UDI — listed in FDA GUDID
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
- BOND™ — Leica Biosystems Newcastle, Limited · 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 III | Pending data |
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Manufacturer
- Manufacturer
- Ventana Medical Systems
Sources (1)
- FDA UDI 657e2a8a-347c-4aa6-94d8-00793e2568e5 33 fields · synced Jun 6, 2026