Identity
- Trade Name
- HER2 IQFISH pharmDx™ FDA UDI
- Generic Name
- HER2/neu/erbB2 mRNA expression IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- HER2 IQFISH pharmDx™ FDA UDI
- Model / Reference
- K5731 FDA UDI
- Description
- HER2 IQFISH pharmDx™ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700572032465 FDA UDI
- FDA Product Code
- MVD FDA UDI
- GMDN Term
- HER2/neu/erbB2 mRNA expression IVD, kit, nucleic acid technique (NAT) 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
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
Category: HER2/neu/erbB2 mRNA expression IVD, kit, nucleic acid technique (NAT)
HER2 IQFISH pharmDx™ by Agilent Technologies Singapore Pte Ltd — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as HER2/neu/erbB2 mRNA expression IVD, kit, nucleic acid technique (NAT).
- HER2 CISH pharmDx™ Kit — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class III
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 22d4b094-db5e-45cf-8253-3c4dbb5f0846 35 fields · synced Jun 6, 2026