Model: T1391
DI: 05700575016899
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
PD-L1 Control Slides
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0aa4b816-e770-4586-95ac-8573118634dc
Distribution Status:
In Commercial Distribution
DUNS Number:
084963177
Device Count:
5
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
Item #1 - Device ID:
05700575016899
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
05700571112755
Item #2 - Device ID Type:
Unit of Use
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 64002
Name: Programmed death-ligand 1 (PD-L1) IVD, control
Definition:
A material which is used to verify the performance of an assay 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
KIR
CELLS, ANIMAL AND HUMAN, CULTURED
Device Sizes
Device Size - Size Text:
Slide
Device Size - Size Type:
Device Size Text, specify
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
2
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
8
Storage Handling - Storage Handling Type:
Storage Environment Temperature