CA15-3 control slides

Basic Information

• Brand Name: CA15-3 control slides
• Primary DI: L502BSB5105
• Version / Model: Control Slides, 5
• Catalog Number: BSB 5105
• Company Name: BIO SB, INC.
• Labeler DUNS: 102855447
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-01
• Public Version: 1
• Public Version Date: 2020-06-09
• Public Version Status: New
• Public Device Record Key: 387f066f-c769-4459-ba38-2a934cef0532

Device Description

CA15-3 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: No
• 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
38222	Cancer antigen 15-3 (CA15-3) 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 cancer antigen 15-3 (CA15-3), a marker commonly associated with breast cancer, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	L502BSB5105	HIBCC