MERIFLUOR EBV VCA IgG/IgM IFA

Basic Information

• Brand Name: MERIFLUOR EBV VCA IgG/IgM IFA
• Primary DI: 00840733102035
• Version / Model: EB211
• Catalog Number: EB211
• Company Name: MERIDIAN BIOSCIENCE, INC.
• Labeler DUNS: 092815364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-21
• Public Version: 1
• Public Version Date: 2020-09-29
• Public Version Status: New
• Public Device Record Key: c881ef5c-f01b-47c0-81e3-9fe511a87986

Device Description

Slides for the detection of EBV VCA IgG/IgM.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
JRY	Antiserum, Fluorescent, Epstein-Barr Virus	Microbiology	866.3235	1

GMDN Terms

Code	Name	Definition	Implantable	Status
49702	Epstein-Barr virus (EBV) 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 antigens from Epstein-Barr virus (EBV) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840733102035	GS1

Premarket Submissions

Submission Number	Supplement Number
K822734	000

Storage Conditions

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