PD-L1 Control Slides

Basic Information

• Brand Name: PD-L1 Control Slides
• Primary DI: 05700573001736
• Version / Model: T1391
• Company Name: AGILENT TECHNOLOGIES, INC.
• Labeler DUNS: 084963177
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2020-11-17
• Public Version: 3
• Public Version Date: 2021-07-26
• Public Version Status: Update
• Public Device Record Key: 1c81ef19-0ab2-4d2e-b15c-8d5f0aa8f4c0

Device Description

PD-L1 Control Slides

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KIR	Cells, Animal And Human, Cultured	Hematology	864.2280	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64002	Programmed death-ligand 1 (PD-L1) IVD, control	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	05700571112755	GS1
Primary	05700573001736	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Slide

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius