QwikCheck Beads

GUDID 07290012140136

M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.

Sperm energy status and motility testing reagent IVD
Primary Device ID07290012140136
NIH Device Record Key47a7c1e6-c703-4155-a7c1-2285bf7a9085
Commercial Distribution StatusIn Commercial Distribution
Brand NameQwikCheck Beads
Version Model NumberQwikCheck Beads 3 Levels
Company DUNS514680529
Company NameM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290012140136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NRFMaterial, Quality Control, Semen Analysis

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-16
Device Publish Date2023-06-08

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

07290016650402 - SQA-iO Sperm Quality Analyzer2023-09-14
07290012140136 - QwikCheck Beads2023-06-16
07290012140136 - QwikCheck Beads2023-06-16
07290012140143 - QwikCheck Dilution Kit2023-06-16
07290012140150 - QwikCheck Liquefaction2023-06-16
07290012140600 - QwikCheck Beads Proficiency and Training Kit2023-06-16
07290012140891 - QwikCheck Vitality Kit2023-06-16
07290016650020 - QwikCheck Beads Precision and Linearity kit2023-06-16
07290016650617 - QwikCheck DFI Kit2023-06-16

Trademark Results [QwikCheck Beads]

Mark Image

Registration | Serial
Company
Trademark
Application Date
QWIKCHECK BEADS
QWIKCHECK BEADS
78412129 3083631 Live/Registered
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
2004-05-03

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