Identity
- Trade Name
- Genemed® FDA UDI
- Generic Name
- Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody FDA UDI
- Device Name
- anti-HER2 Rabbit Monoclonal Antibody [GR011], Ready-To-Use, 15 mL FDA UDI
- Model / Reference
- 60-0221-15 FDA UDI
- Description
- anti-HER2 Rabbit Monoclonal Antibody [GR011], Ready-To-Use, 15 mL FDA UDI
Identifiers
- Catalog Number
- 60-0221-15 FDA UDI
- Primary DI / UDI-DI
- 00615233008183 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
Yes
FDA UDI
Category: Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody
Genemed® by Sakura Finetek USA, Inc — 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
- Sakura Finetek USA, Inc
Sources (1)
- FDA UDI 8d92ba9b-3e53-432c-93c7-d5074e8b1794 35 fields · synced May 30, 2026