MeMed BV®

Basic Information

• Brand Name: MeMed BV®
• Primary DI: 17290018739010
• Version / Model: FG10001
• Company Name: MEMED DIAGNOSTICS LTD
• Labeler DUNS: 533243445
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2021-12-06
• Public Version: 4
• Public Version Date: 2024-01-18
• Public Version Status: Update
• Public Device Record Key: 8087f412-c968-43d2-a94b-20599b84756f

Device Characteristics

• Single Use: Yes
• 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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
QPS	Immunoassay For Host Biomarkers Of Infection	Microbiology	866.3215	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65778	Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple cell-mediated (i.e., non-immunoglobulin) host immune response markers of bacterial and/or viral infection in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a chemiluminescent immunoassay method. It is typically used to differentiate bacterial from viral infection, and/or to predict patient outcomes by grading disease severity. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	17290018739010	GS1
Unit of Use	07290018739013	GS1

Premarket Submissions

Submission Number	Supplement Number
K210254	000