QwikCheck Test Strips 0700

GUDID 07290012140167

M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.

Multiple urine analyte IVD, kit, colorimetric dipstick, rapid

• Primary Device ID: 07290012140167
• NIH Device Record Key: 1a5b9f34-1877-4cf3-bcd3-6ec2c506d26b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QwikCheck Test Strips
• Version Model Number: 0700
• Catalog Number: 0700
• Company DUNS: 514680529
• Company Name: M.E.S. MEDICAL ELECTRONIC SYSTEMS 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: true
• 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	07290012140167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063864

FDA Product Code

• GKZ: Counter, Differential Cell

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-29

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