PD-L1 Control Slides
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- PD-L1 Control Slides EUDAMEDFDA UDI
- Generic Name
- Programmed death-ligand 1 (PD-L1) IVD, control FDA UDI
- Device Name
- PD-L1 Control Slides EUDAMEDFDA UDI
- Model / Reference
- T1391 EUDAMEDFDA UDIT139130-2 EUDAMED
- Description
- PD-L1 Control Slides FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700573001736 EUDAMEDFDA UDI
- Basic UDI-DI
- 570057P3007P3010A054501P6 EUDAMED
- FDA Product Code
- KIR FDA UDI
- EMDN Code
- W0102152005 TUMOUR MARKER CONTROLS EUDAMED
- GMDN Term
- Programmed death-ligand 1 (PD-L1) IVD, control FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 864.2280 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Programmed death-ligand 1 (PD-L1) IVD, control
PD-L1 Control Slides by Agilent Technologies Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Programmed death-ligand 1 (PD-L1) IVD, control.
- PD-L1/CD274 Control Slides — BIO SB, INC. · Class I
- PD-L1/CD274 control slides — BIO SB, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Agilent Technologies Inc.
Sources (2)
- FDA UDI 1c81ef19-0ab2-4d2e-b15c-8d5f0aa8f4c0 36 fields · synced Jun 19, 2026
- EUDAMED 162ef253-8b91-4088-ab76-1ad4b5dc8522 61 fields · synced Jun 19, 2026