QwikCheck Dilution Kit

GUDID 07290012140143

M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.

Sperm energy status and motility testing reagent IVD

• Primary Device ID: 07290012140143
• NIH Device Record Key: b571924f-45e1-46c7-932b-ee36ff7ccc37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QwikCheck Dilution Kit
• Version Model Number: QwikCheck Dilution Kit
• Company DUNS: 514680529
• Company Name: M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290012140143 [Primary]

FDA Product Code

• KIP: Formulations, Balanced Salt Solutions

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: 2023-06-16
• Device Publish Date: 2023-06-08

Devices Manufactured by M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.

• 07290016650402 - SQA-iO Sperm Quality Analyzer: 2023-09-14
• 07290012140136 - QwikCheck Beads: 2023-06-16
• 07290012140143 - QwikCheck Dilution Kit: 2023-06-16
• 07290012140143 - QwikCheck Dilution Kit: 2023-06-16
• 07290012140150 - QwikCheck Liquefaction: 2023-06-16
• 07290012140600 - QwikCheck Beads Proficiency and Training Kit: 2023-06-16
• 07290012140891 - QwikCheck Vitality Kit: 2023-06-16
• 07290016650020 - QwikCheck Beads Precision and Linearity kit: 2023-06-16
• 07290016650617 - QwikCheck DFI Kit: 2023-06-16