Identity
- Trade Name
- MAGE-A4 IHC 1F9 pharmDx FDA UDI
- Generic Name
- Melanoma-associated antigen (MAGE) IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- MAGE-A4 IHC 1F9 pharmDx FDA UDI
- Model / Reference
- SK032 FDA UDI
- Description
- MAGE-A4 IHC 1F9 pharmDx FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700573007400 FDA UDI
- PMA Number
- P230016 FDA UDI
- FDA Product Code
- SBL FDA UDI
- GMDN Term
- Melanoma-associated antigen (MAGE) IVD, kit, enzyme immunohistochemistry FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 864.1860 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: Melanoma-associated antigen (MAGE) IVD, kit, enzyme immunohistochemistry
MAGE-A4 IHC 1F9 pharmDx by Agilent Technologies Inc. — 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 Inc.
Sources (1)
- FDA UDI 9c30af27-07a0-4aea-92f2-df2c723166fd 37 fields · synced May 31, 2026