Respiratory Syncytial Virus Antigen Control Slide, 2 wells

Basic Information

• Brand Name: Respiratory Syncytial Virus Antigen Control Slide, 2 wells
• Primary DI: B110QRS90020
• Version / Model: QRS-9002
• Catalog Number: QRS-9002
• Company Name: Bion Enterprises, Ltd.
• Labeler DUNS: 024824641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 4
• Public Version Date: 2020-03-04
• Public Version Status: Update
• Public Device Record Key: 55ee6fc0-b211-4cae-828f-051c3b95202b

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
LJG	Quality Control Slides	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52808	Respiratory syncytial virus (RSV) antigen 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 antigens from respiratory syncytial virus (RSV) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B110QRS90020	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K890616	000

Storage Conditions

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