Identity
- Trade Name
- PD-L1 IHC 22C3 pharmDx FDA UDI
- Generic Name
- Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- PD-L1 IHC 22C3 pharmDx FDA UDI
- Model / Reference
- GE006 FDA UDI
- Description
- PD-L1 IHC 22C3 pharmDx FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700573003563 FDA UDI
- PMA Number
- P150013 FDA UDI
- FDA Product Code
- PLS FDA UDI
- GMDN Term
- Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry 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: Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry
PD-L1 IHC 22C3 pharmDx by Agilent Technologies Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry.
- PD-L1 — BIOCARE MEDICAL, LLC · Class I
- PD-L1 IHC 22C3 pharmDx — Agilent Technologies Inc. · Class III
- PD-L1 IHC 28-8 pharmDx — Agilent Technologies Inc. · Class III
Cleared under the same submission
P150013 also covers:
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 d825e5ae-5ef2-4c3f-ba89-f023558779bd 36 fields · synced Jun 1, 2026