Identity
- Trade Name
- ANTI-C-ERBB-2 FDA UDI
- Generic Name
- Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody FDA UDI
- Model / Reference
- NU753-UC FDA UDI
Identifiers
- Catalog Number
- NU753-UC FDA UDI
- Primary DI / UDI-DI
- 00810119679062 FDA UDI
- FDA Product Code
- MVU 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
- 864.4020 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
No
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
Dimensions & Sizes
- Size
- Total Volume — 1 Milliliter FDA UDI
Category: Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody
Anti-C-Erbb-2 by Biogenex Laboratories, Inc. — 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
- 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
- Poly Rb A-Hu c-erbB-2 Oncoprotein — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- c-erbB-2/HER2 — BIOCARE MEDICAL, LLC · 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
- Biogenex Laboratories, Inc.
Sources (1)
- FDA UDI 343d6ead-7321-44bf-8b97-01160c09126f 36 fields · synced Jun 8, 2026