MeMed BV® External Control

GUDID 17290018739034

MEMED DIAGNOSTICS LTD

Multiple-marker bacterial/viral infection differentiation IVD, control

• Primary Device ID: 17290018739034
• NIH Device Record Key: 3ca5608d-1fd4-4dda-9818-5ae993faaaf8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MeMed BV® External Control
• Version Model Number: FG12001
• Company DUNS: 533243445
• Company Name: MEMED DIAGNOSTICS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290018739034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210254

FDA Product Code

• QPS: Immunoassay For Host Biomarkers Of Infection

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-03
• Device Publish Date: 2021-10-26

Devices Manufactured by MEMED DIAGNOSTICS LTD

• 17290018739089 - MeMed BV® Calibrator: 2023-07-25
• 17290018739072 - Performance Verification Kit for MeMed Tests Based On TRAIL/ IP-10/ CRP: 2022-09-30 The Performance Verification Kit contains a set of serum-based quantitative samples intended for manual use by healthcare profes
• 17290018739010 - MeMed BV®: 2021-12-14
• 17290018739003 - MeMed Key®: 2021-11-03
• 17290018739027 - MeMed BV® Calibrator: 2021-11-03
• 17290018739034 - MeMed BV® External Control: 2021-11-03
• 17290018739034 - MeMed BV® External Control: 2021-11-03