MeMed BV® Calibrator

GUDID 17290018739027

MEMED DIAGNOSTICS LTD

Multiple-marker bacterial/viral infection differentiation IVD, calibrator

• Primary Device ID: 17290018739027
• NIH Device Record Key: 4a5da084-9d25-4e2f-a669-335e30c51ae3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MeMed BV® Calibrator
• Version Model Number: FG11001
• 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	17290018739027 [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

On-Brand Devices [MeMed BV® Calibrator]

• 17290018739027: FG11001
• 17290018739089: FG31001