MeMed BV® Calibrator

GUDID 17290018739089

MEMED DIAGNOSTICS LTD

Multiple cell-mediated host immune response marker IVD, calibrator

• Primary Device ID: 17290018739089
• NIH Device Record Key: 8f529ca8-cbe6-4aa0-8f07-cc9332fd7596
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MeMed BV® Calibrator
• Version Model Number: FG31001
• 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: false
• Manufacturing Date: true
• Expiration Date: true
• 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	17290018739089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230944

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: 2023-07-25
• Device Publish Date: 2023-07-17

On-Brand Devices [MeMed BV® Calibrator]

• 17290018739027: FG11001
• 17290018739089: FG31001