QwikCheck Beads Precision and Linearity kit

Basic Information

• Brand Name: QwikCheck Beads Precision and Linearity kit
• Primary DI: 07290016650020
• Version / Model: QwikCheck Beads Precision and Linearity kit
• Company Name: M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
• Labeler DUNS: 514680529
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-08
• Public Version: 1
• Public Version Date: 2023-06-16
• Public Version Status: New
• Public Device Record Key: cedb5354-d783-4a2c-ac92-a1e7a07c31db

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRF	Material, Quality Control, Semen Analysis	Hematology	864.8625	2
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60012	Sperm energy status and motility testing reagent IVD	A sterile substance or reactant intended to be added to a semen specimen during a spermiogram test, in order to assess the energy status and the potential for increasing the motility rate of sperm through clinical treatment. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016650020	GS1

Premarket Submissions

Submission Number	Supplement Number
K041600	000