Light Diagnostics ™ Coxsackievirus B Control Slides

Basic Information

• Brand Name: Light Diagnostics ™ Coxsackievirus B Control Slides
• Primary DI: 04053252729225
• Version / Model: 5075
• Catalog Number: 5075
• Company Name: EMD Millipore Corporation
• Labeler DUNS: 829517072
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-30
• Public Version: 2
• Public Version Date: 2023-08-25
• Public Version Status: Update
• Public Device Record Key: b7639cbd-fd73-480f-8c26-0405d3e18dce
• Distribution End Date: 2023-04-30

Device Description

Coxsackievirus B Control Slides

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
GNM	Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6	Microbiology	866.3145	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48561	Coxsackie A/B virus antigen IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of multiple Coxsackie virus antigens from group A and B in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04053252729225	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K940471	000

Storage Conditions

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