PD-L1/CD274 control slides

Basic Information

• Brand Name: PD-L1/CD274 control slides
• Primary DI: B502BSB26550
• Version / Model: Control Slides, 5
• Catalog Number: BSB 2655
• Company Name: BIO SB, INC.
• Labeler DUNS: 102855447
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-31
• Public Version: 1
• Public Version Date: 2020-09-08
• Public Version Status: New
• Public Device Record Key: 72868fd2-bb34-49e5-94a6-970fc40c946c

Device Description

PD-L1/CD274 control

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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LJG	Quality Control Slides	Microbiology	866.2660	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
Primary	B502BSB26550	HIBCC