Identity
- Trade Name
- HercepTest™ for the Dako Autostainer FDA UDI
- Generic Name
- Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- HercepTest for the Dako Autostainer FDA UDI
- Model / Reference
- K5207 FDA UDI
- Description
- HercepTest for the Dako Autostainer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700572031994 FDA UDI
- FDA Product Code
- MVC FDA UDI
- GMDN Term
- Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, enzyme immunohistochemistry FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not 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
Yes
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
HercepTest™ for the Dako Autostainer by Agilent Technologies Singapore Pte Ltd — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Agilent Technologies Singapore Pte Ltd
Sources (1)
- FDA UDI d58678d3-2469-46a9-b4e6-7f22e757157b 37 fields · synced May 30, 2026