Model: PDM572-25
DI: 00846405000005
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
PD-L1, Clone 405-9A11, 25 ml
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c005be20-f946-4866-ab4e-0f44d9828dbe
Distribution Status:
In Commercial Distribution
DUNS Number:
926549064
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00846405000005
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 62046
Name: Programmed death-ligand 1 (PD-L1) IVD, antibody
Definition:
One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of programmed death-ligand 1 (PD-L1), also known as CD274, in a clinical specimen.
FDA Product Codes
NJT
Immunohistochemistry Reagents And Kits