Identity
- Trade Name
- Anti PD-L1 Antibody FDA UDI
- Generic Name
- Programmed death-ligand 1 (PD-L1) IVD, antibody FDA UDI
- Device Name
- Anti PD-L1 Antibody is a rabbit monoclonal antibody to PD-L1 [28-8] conjugated with Alexa Fluor 647. FDA UDI
- Model / Reference
- C31050 FDA UDI
- Description
- Anti PD-L1 Antibody is a rabbit monoclonal antibody to PD-L1 [28-8] conjugated with Alexa Fluor 647. FDA UDI
Identifiers
- Catalog Number
- C31050 FDA UDI
- Primary DI / UDI-DI
- B766C310500 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Programmed death-ligand 1 (PD-L1) IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 55 Microliter FDA UDI
Category: Programmed death-ligand 1 (PD-L1) IVD, antibody
Anti PD-L1 Antibody by Incelldx, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Incelldx, Inc
Sources (1)
- FDA UDI 3e64ee7a-43d6-4aea-a77b-0c3c8197e1dd 36 fields · synced Jun 9, 2026